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Patient Circuit

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref VWSP-1450FModel Ventway Sparrow Patient Circuit

by Inovytec Medical Solutions Ltd.

Identity

Trade Name
Patient Circuit EUDAMED
Patient Circuit - Adult, 1.8m, 1 pcs, one way FDA UDI
Generic Name
Inspiratory/expiratory limb respiratory tubing, single-use FDA UDI
Model / Reference
Ventway Sparrow Patient Circuit EUDAMED
VWSP-1450F EUDAMED
VWSP-450F FDA UDI

Identifiers

Primary DI / UDI-DI
07290017096766 EUDAMEDFDA UDI
Basic UDI-DI
7290017096VentwayPCZ8 EUDAMED
510(k) Number
K202970 FDA UDI
FDA Product Code
CBK FDA UDI
EMDN Code
R020199 BREATHING CIRCUITS AND KITS - OTHER EUDAMED
GMDN Term
Inspiratory/expiratory limb respiratory tubing, single-use FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
868.5895 FDA UDI
Market of Registration
Czechia 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Patient Circuit by Inovytec Medical Solutions Ltd. — 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

Manufacturer
Inovytec Medical Solutions Ltd.
EUDAMED SRN
IL-MF-000034055
Authorised Representative
Obelis s.a. BE-AR-000000106

Sources (2)

  • EUDAMED 7f71d379-5f7f-4d3f-8c5f-289b99883826 61 fields · synced Jul 30, 2026
  • FDA UDI d84229a7-04e3-4df0-8ba8-891e3c29b017 34 fields · synced May 30, 2026