Identity
- Trade Name
- CMO8 Adult PMP Oxygenator with Tubing Pack FDA UDI
- Generic Name
- Extracorporeal membrane oxygenation system circuit FDA UDI
- Device Name
- The CMO8 Adult PMP Oxygenator with Tubing Pack is intended for use in extracorporeal circulation during cardiopulmonary bypass procedures, lasting 6 hours or less. FDA UDI
- Model / Reference
- CME40009 FDA UDI
- Description
- The CMO8 Adult PMP Oxygenator with Tubing Pack is intended for use in extracorporeal circulation during cardiopulmonary bypass procedures, lasting 6 hours or less. FDA UDI
Identifiers
- Catalog Number
- CME40009 FDA UDI
- Primary DI / UDI-DI
- 05060491619810 FDA UDI
- FDA Product Code
- DTZ FDA UDIDWF FDA UDIDTR FDA UDI
- GMDN Term
- Extracorporeal membrane oxygenation system circuit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4350 FDA UDI870.4210 FDA UDI870.4240 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
CMO8 Adult PMP Oxygenator with Tubing Pack by Chalice Medical Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Chalice Medical Limited
Sources (1)
- FDA UDI cd900f1e-8c4c-4613-b41d-35e4a25001fe 37 fields · synced Jun 6, 2026