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Microvent

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref 670-0411-00 Model microVENT Responder Resuscitator, Adult and Child - DISS fitting, green hose, 60 cm H2O relief Ref 670-0223-00 Model microVENT Advanced European Adult and Child Resuscitator - JIS fitting, green hoseRef 670-0307-00 Model microVENT UtilityVenT, Advanced, Adult Resuscitator - DISS fitting, green hose, 45 cm H2O relief Ref 670-0545-00 Model microVENT World, Standard, Airmix, Adult and Child Resuscitator - DIN (Hayer) fitting, white hoseRef 670-0061-00 Model microVENT Classic, Standard, - BS fitting (Schrader probe), white hose Ref 670-0530-00 Model microVENT World, Advanced, Airmix, Adult and Child Resuscitator - DISS fitting, green hose, 45 cm H2O reliefRef 670-0259-00 Model microVENT Industrial, Standard, 'European' Adult Resuscitator - BS fitting (Schrader probe), white hoseRef 670-0228-00 Model microVENT Classic, Advanced, Airmix, Adult and Child Resuscitator - DIN (Hayer) fitting, white hoseRef 670-0603-00 Model microVENT World, Advanced, Adult and Child Resuscitator - DISS fitting, green hose, 60 cm H2O reliefRef 670-0701-00 Model microVENT UtilityVenT, Advanced, Adult Resuscitator - SIS Australian fitting, white hoseRef 670-0483-00 Model microVENT CPR Resuscitator, Standard, Adult and Child - BS fitting (Schrader probe), white hoseRef 670-0299-00 Model microVENT Industrial, Standard, 'European' Adult Resuscitator - AFNOR French fitting, white hoseRef 670-0339-00 Model microVENT UtilityVenT, Advanced, Adult Resuscitator - BS fitting (Schrader probe), white hose Ref 670-0247-00 Model microVENT Advanced European Adult and Child Resuscitator - AGA fitting, white hoseRef 670-0551-00Model microVENT World, Advanced, Airmix, Adult and Child Resuscitator - AGA fitting, white hoseRef 670-0244-00 Model microVENT Classic, Advanced, Airmix, Adult and Child Resuscitator - AGA fitting, white hoseRef 670-0589-00 Model microVENT UtilityVenT, Standard, Adult Resuscitator - AFNOR French fitting, white hose Ref 670-0605-00 Model microVENT CPR Resuscitator, Standard, Adult and Child - DISS fitting, green hose, 60 cm H2O reliefRef 670-0602-00 Model microVENT World, Standard, Airmix, Adult and Child Resuscitator - DISS fitting, green hose, 60 cm H2O reliefRef 670-0406-00 Model microVENT Classic, Standard Adult and Child Resuscitator - DISS fitting, green hose, 60 cm H2O reliefRef 670-0235-00 Model microVENT Classic, Advanced, Adult and Child Resuscitator - DISS fitting, green hose, 45 cm H2O reliefRef 670-0215-00 Model microVENT Advanced European Adult and Child Resuscitator - BS fitting (Schrader probe), white hoseRef 670-0231-00 Model microVENT Advanced European Adult and Child Resuscitator - DIN (Hayer) fitting, white hoseRef 670-0581-00 Model microVENT CPR Resuscitator, Standard, Adult and Child - AFNOR French fitting, white hoseRef 670-0250-00 Model microVENT Classic, Standard, Airmix, Adult and Child Resuscitator - AFNOR French fitting, white hose Ref 670-0692-00 Model microVENT World, Standard, Adult and Child Resuscitator - SIS Australian fitting, white hose Ref 670-0520-00 Model microVENT UtilityVenT, Standard, Adult Resuscitator - AGA fitting, white hoseRef 670-0698-00 Model microVENT World, Standard, Airmix, Adult and Child Resuscitator - SIS Australian fitting, white hoseRef 670-0234-00 Model microVENT Classic, Standard, Airmix, Adult and Child Resuscitator - DISS fitting, green hose, 45 cm H2O reliefRef 670-0403-00 Model microVENT Classic, Advanced, Airmix, Adult and Child Resuscitator -DISS fitting, green hose, 60 cm H2O reliefRef 670-0010-00 Model microVENT Classic, Advanced, Adult and Child Resuscitator - BS fitting (Schrader probe), white hoseRef 670-0511-00 Model microVENT World, Standard, Adult and Child Resuscitator - BS fitting (Schrader probe), white hoseRef 670-0543-00 Model microVENT World, Advanced, Airmix, Adult and Child Resuscitator - JIS fitting, green hoseRef 670-0528-00 Model microVENT World, Advanced, Adult and Child Resuscitator - DISS fitting, green hose, 45 cm H2O reliefRef 670-0542-00 Model microVENT World, Advanced, Adult and Child Resuscitator - JIS fitting, green hoseRef 670-0218-00 Model microVENT Classic, Standard - JIS fitting, green hoseRef 670-0285-00 Model microVENT Industrial, Advanced, 'European' Adult Resuscitator - DISS fitting, green hose, 60 cm H2O relief Ref 670-0410-00 Model microVENT Industrial, Standard, 'European' Adult Resuscitator - DISS fitting, green hose, 60 cm H2O reliefRef 670-0588-00 Model microVENT UtilityVenT, Standard, Adult Resuscitator - DISS fitting, green hose, 45 cm H2O reliefRef 670-0409-00 Model microVENT Industrial, Advanced, 'European' Adult Resuscitator - DISS fitting, green hose, 60 cm H2O reliefRef 670-0584-00 Model microVENT UtilityVenT, Standard, Adult Resuscitator - JIS fitting, green hose Ref 670-0691-00 Model microVENT World, Advanced, Adult and Child Resuscitator - SIS Australian fitting, white hoseRef 670-0514-00 Model microVENT UtilityVenT, Advanced, Adult Resuscitator - AGA fitting, white hoseRef 670-0314-00 Model microVENT Responder Resuscitator, Adult and Child - JIS fitting, green hoseRef 670-0060-00 Model microVENT Classic, Advanced, Airmix, Adult and Child Resuscitator - BS fitting (Schrader probe), white hoseRef 670-0607-00 Model microVENT UtilityVenT, Standard, Adult Resuscitator - DISS fitting, green hose, 60 cm H2O reliefRef 670-0508-00 Model microVENT Advanced European Adult and Child Resuscitator - DISS fitting, green hose, 60 cm H2O reliefRef 670-0555-00 Model microVENT World, Advanced, Airmix, Adult and Child Resuscitator - AFNOR French fitting, white hoseRef 670-0241-00 Model microVENT Classic, Standard Adult and Child Resuscitator - AGA fitting, white hoseRef 670-0606-00 Model microVENT UtilityVenT, Advanced, Adult Resuscitator - DISS fitting, green hose, 60 cm H2O relief510(k) K930533Ref 670-0221-00 Model microVENT Standard European Adult and Child Resuscitator - JIS fitting, green hoseRef 670-0718-00Model microVENT World, Advanced, Airmix, Adult and Child Resuscitator - UNIFOR (Italian) Fitting, White hoseRef 670-0408-00 Model microVENT Standard European Adult and Child Resuscitator - DISS fitting, green hose, 60 cm H2O reliefRef 670-0009-00 Model microVENT Classic, Standard Adult and Child Resuscitator - BS fitting (Schrader probe), white hose Ref 670-0539-00 Model microVENT World, Standard, Airmix, Adult and Child Resuscitator - BS fitting (Schrader probe), white hoseRef 670-0275-00 Model microVENT Industrial, Standard, 'European' Adult Resuscitator - DIN (Hayer) fitting, white hoseRef 670-0728-00Model Microvent Lithuania Spec, A/C Adv, AGA Hose, Stretcher BracketRef 670-0585-00 Model microVENT UtilityVenT, Advanced, Adult Resuscitator - JIS fitting, green hoseRef 670-0217-00 Model microVENT Classic, Standard Adult and Child Resuscitator - JIS fitting, green hose Ref 670-0226-00 Model microVENT Classic, Standard - DIN (Hayer) fitting, white hose Ref 670-0544-00 Model microVENT World, Standard, Adult and Child Resuscitator - DIN (Hayer) fitting, white hose

by BNOS MediTECH

Identity

Trade Name
Microvent EUDAMED
Device Name
Microvent EUDAMED
Model / Reference
microVENT Responder Resuscitator, Adult and Child - DISS fitting, green hose, 60 cm H2O relief EUDAMED
670-0411-00 EUDAMED
microVENT Advanced European Adult and Child Resuscitator - JIS fitting, green hose EUDAMED
670-0223-00 EUDAMED
microVENT UtilityVenT, Advanced, Adult Resuscitator - DISS fitting, green hose, 45 cm H2O relief EUDAMED
670-0307-00 EUDAMED
microVENT World, Standard, Airmix, Adult and Child Resuscitator - DIN (Hayer) fitting, white hose EUDAMED
670-0545-00 EUDAMED
microVENT Classic, Standard, - BS fitting (Schrader probe), white hose EUDAMED
670-0061-00 EUDAMED
microVENT World, Advanced, Airmix, Adult and Child Resuscitator - DISS fitting, green hose, 45 cm H2O relief EUDAMED
670-0530-00 EUDAMED
microVENT Industrial, Standard, 'European' Adult Resuscitator - BS fitting (Schrader probe), white hose EUDAMED
670-0259-00 EUDAMED
microVENT Classic, Advanced, Airmix, Adult and Child Resuscitator - DIN (Hayer) fitting, white hose EUDAMED
670-0228-00 EUDAMED
microVENT World, Advanced, Adult and Child Resuscitator - DISS fitting, green hose, 60 cm H2O relief EUDAMED
670-0603-00 EUDAMED
microVENT UtilityVenT, Advanced, Adult Resuscitator - SIS Australian fitting, white hose EUDAMED
670-0701-00 EUDAMED
microVENT CPR Resuscitator, Standard, Adult and Child - BS fitting (Schrader probe), white hose EUDAMED
670-0483-00 EUDAMED
microVENT Industrial, Standard, 'European' Adult Resuscitator - AFNOR French fitting, white hose EUDAMED
670-0299-00 EUDAMED
microVENT UtilityVenT, Advanced, Adult Resuscitator - BS fitting (Schrader probe), white hose EUDAMED
670-0339-00 EUDAMED
microVENT Advanced European Adult and Child Resuscitator - AGA fitting, white hose EUDAMED
670-0247-00 EUDAMED
microVENT World, Advanced, Airmix, Adult and Child Resuscitator - AGA fitting, white hose EUDAMED
670-0551-00 EUDAMED
microVENT Classic, Advanced, Airmix, Adult and Child Resuscitator - AGA fitting, white hose EUDAMED
670-0244-00 EUDAMED
microVENT UtilityVenT, Standard, Adult Resuscitator - AFNOR French fitting, white hose EUDAMED
670-0589-00 EUDAMED
microVENT CPR Resuscitator, Standard, Adult and Child - DISS fitting, green hose, 60 cm H2O relief EUDAMED
670-0605-00 EUDAMED
microVENT World, Standard, Airmix, Adult and Child Resuscitator - DISS fitting, green hose, 60 cm H2O relief EUDAMED
670-0602-00 EUDAMED
microVENT Classic, Standard Adult and Child Resuscitator - DISS fitting, green hose, 60 cm H2O relief EUDAMED
670-0406-00 EUDAMED
microVENT Classic, Advanced, Adult and Child Resuscitator - DISS fitting, green hose, 45 cm H2O relief EUDAMED
670-0235-00 EUDAMED
microVENT Advanced European Adult and Child Resuscitator - BS fitting (Schrader probe), white hose EUDAMED
670-0215-00 EUDAMED
microVENT Advanced European Adult and Child Resuscitator - DIN (Hayer) fitting, white hose EUDAMED
670-0231-00 EUDAMED
microVENT CPR Resuscitator, Standard, Adult and Child - AFNOR French fitting, white hose EUDAMED
670-0581-00 EUDAMED
microVENT Classic, Standard, Airmix, Adult and Child Resuscitator - AFNOR French fitting, white hose EUDAMED
670-0250-00 EUDAMED
microVENT World, Standard, Adult and Child Resuscitator - SIS Australian fitting, white hose EUDAMED
670-0692-00 EUDAMED
microVENT UtilityVenT, Standard, Adult Resuscitator - AGA fitting, white hose EUDAMED
670-0520-00 EUDAMED
microVENT World, Standard, Airmix, Adult and Child Resuscitator - SIS Australian fitting, white hose EUDAMED
670-0698-00 EUDAMED
microVENT Classic, Standard, Airmix, Adult and Child Resuscitator - DISS fitting, green hose, 45 cm H2O relief EUDAMED
670-0234-00 EUDAMED
microVENT Classic, Advanced, Airmix, Adult and Child Resuscitator -DISS fitting, green hose, 60 cm H2O relief EUDAMED
670-0403-00 EUDAMED
microVENT Classic, Advanced, Adult and Child Resuscitator - BS fitting (Schrader probe), white hose EUDAMED
670-0010-00 EUDAMED
microVENT World, Standard, Adult and Child Resuscitator - BS fitting (Schrader probe), white hose EUDAMED
670-0511-00 EUDAMED
microVENT World, Advanced, Airmix, Adult and Child Resuscitator - JIS fitting, green hose EUDAMED
670-0543-00 EUDAMED
microVENT World, Advanced, Adult and Child Resuscitator - DISS fitting, green hose, 45 cm H2O relief EUDAMED
670-0528-00 EUDAMED
microVENT World, Advanced, Adult and Child Resuscitator - JIS fitting, green hose EUDAMED
670-0542-00 EUDAMED
microVENT Classic, Standard - JIS fitting, green hose EUDAMED
670-0218-00 EUDAMED
microVENT Industrial, Advanced, 'European' Adult Resuscitator - DISS fitting, green hose, 60 cm H2O relief EUDAMED
670-0285-00 EUDAMED
microVENT Industrial, Standard, 'European' Adult Resuscitator - DISS fitting, green hose, 60 cm H2O relief EUDAMED
670-0410-00 EUDAMED
microVENT UtilityVenT, Standard, Adult Resuscitator - DISS fitting, green hose, 45 cm H2O relief EUDAMED
670-0588-00 EUDAMED
670-0409-00 EUDAMED
microVENT UtilityVenT, Standard, Adult Resuscitator - JIS fitting, green hose EUDAMED
670-0584-00 EUDAMED
microVENT World, Advanced, Adult and Child Resuscitator - SIS Australian fitting, white hose EUDAMED
670-0691-00 EUDAMED
microVENT UtilityVenT, Advanced, Adult Resuscitator - AGA fitting, white hose EUDAMED
670-0514-00 EUDAMED
microVENT Responder Resuscitator, Adult and Child - JIS fitting, green hose EUDAMED
670-0314-00 EUDAMED
microVENT Classic, Advanced, Airmix, Adult and Child Resuscitator - BS fitting (Schrader probe), white hose EUDAMED
670-0060-00 EUDAMED
microVENT UtilityVenT, Standard, Adult Resuscitator - DISS fitting, green hose, 60 cm H2O relief EUDAMED
670-0607-00 EUDAMED
microVENT Advanced European Adult and Child Resuscitator - DISS fitting, green hose, 60 cm H2O relief EUDAMED
670-0508-00 EUDAMED
microVENT World, Advanced, Airmix, Adult and Child Resuscitator - AFNOR French fitting, white hose EUDAMED
670-0555-00 EUDAMED
microVENT Classic, Standard Adult and Child Resuscitator - AGA fitting, white hose EUDAMED
670-0241-00 EUDAMED
microVENT UtilityVenT, Advanced, Adult Resuscitator - DISS fitting, green hose, 60 cm H2O relief EUDAMED
670-0606-00 EUDAMED
microVENT Standard European Adult and Child Resuscitator - JIS fitting, green hose EUDAMED
670-0221-00 EUDAMED
microVENT World, Advanced, Airmix, Adult and Child Resuscitator - UNIFOR (Italian) Fitting, White hose EUDAMED
670-0718-00 EUDAMED
microVENT Standard European Adult and Child Resuscitator - DISS fitting, green hose, 60 cm H2O relief EUDAMED
670-0408-00 EUDAMED
microVENT Classic, Standard Adult and Child Resuscitator - BS fitting (Schrader probe), white hose EUDAMED
670-0009-00 EUDAMED
microVENT World, Standard, Airmix, Adult and Child Resuscitator - BS fitting (Schrader probe), white hose EUDAMED
670-0539-00 EUDAMED
microVENT Industrial, Standard, 'European' Adult Resuscitator - DIN (Hayer) fitting, white hose EUDAMED
670-0275-00 EUDAMED
Microvent Lithuania Spec, A/C Adv, AGA Hose, Stretcher Bracket EUDAMED
670-0728-00 EUDAMED
microVENT UtilityVenT, Advanced, Adult Resuscitator - JIS fitting, green hose EUDAMED
670-0585-00 EUDAMED
microVENT Classic, Standard Adult and Child Resuscitator - JIS fitting, green hose EUDAMED
670-0217-00 EUDAMED
microVENT Classic, Standard - DIN (Hayer) fitting, white hose EUDAMED
670-0226-00 EUDAMED
microVENT World, Standard, Adult and Child Resuscitator - DIN (Hayer) fitting, white hose EUDAMED
670-0544-00 EUDAMED

Identifiers

Primary DI / UDI-DI
05052270201392 EUDAMED
05052270200982 EUDAMED
05052270201293 EUDAMED
05052270200487 EUDAMED
05052270200081 EUDAMED
05052270200555 EUDAMED
05052270201088 EUDAMED
05052270200784 EUDAMED
05052270200531 EUDAMED
05052270201538 EUDAMED
05052270200043 EUDAMED
05052270201323 EUDAMED
05052270201095 EUDAMED
05052270200968 EUDAMED
05052270200395 EUDAMED
05052270200708 EUDAMED
05052270201347 EUDAMED
05052270200661 EUDAMED
05052270200524 EUDAMED
05052270200852 EUDAMED
05052270200883 EUDAMED
05052270200944 EUDAMED
05052270201002 EUDAMED
05052270200685 EUDAMED
05052270200913 EUDAMED
05052270201491 EUDAMED
05052270201149 EUDAMED
05052270201477 EUDAMED
05052270200876 EUDAMED
05052270200821 EUDAMED
05052270200005 EUDAMED
05052270200074 EUDAMED
05052270200432 EUDAMED
05052270200579 EUDAMED
05052270200456 EUDAMED
05052270200753 EUDAMED
05052270201279 EUDAMED
05052270201248 EUDAMED
05052270201309 EUDAMED
05052270201231 EUDAMED
05052270201187 EUDAMED
05052270201484 EUDAMED
05052270201132 EUDAMED
05052270201378 EUDAMED
05052270200692 EUDAMED
05052270201262 EUDAMED
05052270201026 EUDAMED
05052270200593 EUDAMED
05052270200739 EUDAMED
05052270201255 EUDAMED
05052270200999 EUDAMED
05052270201804 EUDAMED
05052270201033 EUDAMED
05052270200067 EUDAMED
05052270200098 EUDAMED
05052270201200 EUDAMED
05052270201958 EUDAMED
05052270201170 EUDAMED
05052270200777 EUDAMED
05052270200791 EUDAMED
05052270200500 EUDAMED
Basic UDI-DI
B-05052270201392 EUDAMED
B-05052270200982 EUDAMED
B-05052270201293 EUDAMED
B-05052270200487 EUDAMED
B-05052270200081 EUDAMED
B-05052270200555 EUDAMED
B-05052270201088 EUDAMED
B-05052270200784 EUDAMED
B-05052270200531 EUDAMED
B-05052270201538 EUDAMED
B-05052270200043 EUDAMED
B-05052270201323 EUDAMED
B-05052270201095 EUDAMED
B-05052270200968 EUDAMED
B-05052270200395 EUDAMED
B-05052270200708 EUDAMED
B-05052270201347 EUDAMED
B-05052270200661 EUDAMED
B-05052270200524 EUDAMED
B-05052270200852 EUDAMED
B-05052270200883 EUDAMED
B-05052270200944 EUDAMED
B-05052270201002 EUDAMED
B-05052270200685 EUDAMED
B-05052270200913 EUDAMED
B-05052270201491 EUDAMED
B-05052270201149 EUDAMED
B-05052270201477 EUDAMED
B-05052270200876 EUDAMED
B-05052270200821 EUDAMED
B-05052270200005 EUDAMED
B-05052270200074 EUDAMED
B-05052270200432 EUDAMED
B-05052270200579 EUDAMED
B-05052270200456 EUDAMED
B-05052270200753 EUDAMED
B-05052270201279 EUDAMED
B-05052270201248 EUDAMED
B-05052270201309 EUDAMED
B-05052270201231 EUDAMED
B-05052270201187 EUDAMED
B-05052270201484 EUDAMED
B-05052270201132 EUDAMED
B-05052270201378 EUDAMED
B-05052270200692 EUDAMED
B-05052270201262 EUDAMED
B-05052270201026 EUDAMED
B-05052270200593 EUDAMED
B-05052270200739 EUDAMED
B-05052270201255 EUDAMED
B-05052270200999 EUDAMED
B-05052270201804 EUDAMED
B-05052270201033 EUDAMED
B-05052270200067 EUDAMED
B-05052270200098 EUDAMED
B-05052270201200 EUDAMED
B-05052270201958 EUDAMED
B-05052270201170 EUDAMED
B-05052270200777 EUDAMED
B-05052270200791 EUDAMED
B-05052270200500 EUDAMED
510(k) Number
K930533 FDA 510(k)
FDA Product Code
BZT FDA 510(k)
EMDN Code
Z12030103 PULMONARY VENTILATORS FOR NON–HOSPITAL USE EUDAMED
Z12030104 PORTABLE PULMONARY VENTILATORS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.1920 FDA 510(k)
Regulation Number
868.1920 FDA 510(k)
Market of Registration
Netherlands EUDAMED
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

Yes

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Microvent by BNOS MediTECH — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDD

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
BNOS MediTECH
EUDAMED SRN
GB-MF-000008883
Authorised Representative
Medical Device Management Ltd IE-AR-000002496

Sources (62)

  • EUDAMED 715e6b55-e623-44f2-a9f9-948fdec8c915 61 fields · synced Sep 17, 2026
  • EUDAMED 0da7354f-d7d6-4c18-9d48-e188725010d0 61 fields · synced May 11, 2026
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  • EUDAMED b74535bb-0e38-4bef-8ae5-44a31cba32fb 61 fields · synced May 17, 2026
  • EUDAMED 6a8a8fc9-d3f8-4804-8747-4ed395856f3b 61 fields · synced May 17, 2026
  • EUDAMED 38bdd45f-797e-435d-bf17-6293d4467fdb 61 fields · synced May 18, 2026
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  • EUDAMED bdc0acb1-a0dd-4b63-b51f-284500045763 61 fields · synced May 18, 2026
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