Identity
- Trade Name
- Abiomed Breethe OXY-1 System FDA UDI
- Generic Name
- Extracorporeal membrane oxygenator FDA UDI
- Device Name
- OXY-1 Condensate Tray Qty 5 FDA UDI
- Model / Reference
- 001-0403-006 FDA UDI
- Description
- OXY-1 Condensate Tray Qty 5 FDA UDI
Identifiers
- Catalog Number
- 001-0403-006 FDA UDI
- Primary DI / UDI-DI
- 00813502012354 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
- 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
Category: Extracorporeal membrane oxygenator
Abiomed Breethe OXY-1 System by Breethe, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Extracorporeal membrane oxygenator.
- INSPIRE — SORIN GROUP ITALIA SRL · Class II
- Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir — Terumo Cardiovascular Systems Corporation · Class II
- AMG PMP INFANT STERILE — EUROSETS SRL · Class II
- Affinity Fusion® — MEDTRONIC, INC. · Class II
- MC3 Nautilus ECMO Oxygenator — MICHIGAN CRITICAL CARE CONSULTANTS, INC. · Class II
- CAPIOX — Terumo Corp. · Class II
- CAPIOX®RX — Terumo Corp. · Class II
- Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res. — Terumo Cardiovascular Systems Corporation · Class II
Cleared under the same submission
K223161 also covers:
- Abiomed Breethe OXY-1 System — Breethe, Inc.
- Abiomed Breethe OXY-1 System — Breethe, Inc.
- Abiomed Breethe OXY-1 System — Breethe, Inc.
- Abiomed Breethe OXY-1 System — Breethe, Inc.
- Abiomed Breethe OXY-1 System — Breethe, Inc.
- Abiomed Breethe OXY-1 System — Breethe, Inc.
- Abiomed Breethe OXY-1 System — Breethe, Inc.
- Abiomed Breethe OXY-1 System — Breethe, Inc.
- Abiomed Breethe OXY-1 System — Breethe, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Breethe, Inc.
Sources (1)
- FDA UDI 2c0bf925-62bb-4c06-a322-f2d3ca52e46f 35 fields · synced May 31, 2026