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Abiomed Breethe OXY-1 System

FDA UDI

Class II (US FDA UDI)

by Breethe, Inc.

Identity

Trade Name
Abiomed Breethe OXY-1 System FDA UDI
Generic Name
Extracorporeal membrane oxygenator FDA UDI
Device Name
Condensation Tray Pouch Assembly FDA UDI
Model / Reference
001-0403-004 FDA UDI
Description
Condensation Tray Pouch Assembly FDA UDI

Identifiers

Catalog Number
001-0403-004 FDA UDI
Primary DI / UDI-DI
10860001797920 FDA UDI
510(k) Number
K223161 FDA UDI
FDA Product Code
DTZ FDA UDI
GMDN Term
Extracorporeal membrane oxygenator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4350 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Abiomed Breethe OXY-1 System by Breethe, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K223161 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Breethe, Inc.

Sources (1)

  • FDA UDI dc93cb7d-9857-4fad-b521-9b00718fb931 36 fields · synced May 30, 2026