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CMO8 Adult PMP Oxygenator with Tubing Pack

FDA UDI

Class II (US FDA UDI)

by Chalice Medical Limited

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
05060912587483 FDA UDI
FDA Product Code
DTZ FDA UDI
DWF FDA UDI
DTR FDA UDI
GMDN Term
Extracorporeal membrane oxygenation system circuit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4350 FDA UDI
870.4210 FDA UDI
870.4240 FDA UDI
Commercial Distribution
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

Category: Extracorporeal membrane oxygenation system circuit

CMO8 Adult PMP Oxygenator with Tubing Pack by Chalice Medical Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Extracorporeal membrane oxygenation system circuit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Chalice Medical Limited

Sources (1)

  • FDA UDI 7c35cbad-ed9f-4dee-8abe-cf7957f73107 36 fields · synced Jun 6, 2026