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Disposable Exp. Valve Carina

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref MP00220Model 422495

by Drägerwerk AG & Co. KGaA

Identity

Trade Name
Einweg Exp. Valve Carina EUDAMED
Disposable Exp. Valve Carina FDA UDI
Generic Name
Non-rebreathing valve, reusable FDA UDI
Model / Reference
MP00220 EUDAMEDFDA UDI
422495 EUDAMED

Identifiers

Primary DI / UDI-DI
04048675422495 EUDAMEDFDA UDI
Basic UDI-DI
B-04048675422495 EUDAMED
510(k) Number
K072885 FDA UDI
FDA Product Code
CBK FDA UDI
EMDN Code
Z1203010585 PULMONARY VENTILATORS FOR HOSPITAL USE - CONSUMABLES EUDAMED
GMDN Term
Non-rebreathing valve, reusable FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
868.5895 FDA UDI
Market of Registration
Germany 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

No

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

Category: Non-rebreathing valve, reusable

Disposable Exp. Valve Carina by Drägerwerk AG & Co. KGaA — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Non-rebreathing valve, reusable.

Cleared under the same submission

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

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Manufacturer

Sources (2)

  • FDA UDI 09698965-a08b-4dad-894b-53facc5a5be9 33 fields · synced Jul 10, 2026
  • EUDAMED 9ed52ed8-3977-4cc3-a76c-bedc0216aa13 61 fields · synced Jul 10, 2026