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Breathing system, 22 mm (for HME) 1, 5m

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 6691957

by Maquet Critical Care AB

Identity

Trade Name
Breathing system, 22 mm (for HME) 1,5m EUDAMED
Breathing system 22mm HME Disp 1.5m FDA UDI
Generic Name
Ventilator breathing circuit, single-use FDA UDI
Device Name
Breathing system EUDAMED
Model / Reference
6691957 EUDAMED
6693505 FDA UDI

Identifiers

Primary DI / UDI-DI
07325710002162 EUDAMEDFDA UDI
Basic UDI-DI
73257100021688 EUDAMED
FDA Product Code
BZO FDA UDI
EMDN Code
R02010101 BREATHING CIRCUITS, W/O WATER TRAP EUDAMED
GMDN Term
Ventilator breathing circuit, single-use FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class I FDA UDI
Regulation Number
868.5975 FDA UDI
Market of Registration
Sweden EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Breathing system, 22 mm (for HME) 1, 5m by Maquet Critical Care AB — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

EUDAMED SRN
SE-MF-000001264

Sources (2)

  • EUDAMED 73c98691-8526-43e1-8931-d92c74762370 61 fields · synced Oct 6, 2026
  • FDA UDI 287bcda3-9867-4bf0-9108-05e7aeafae02 32 fields · synced May 30, 2026