← Back to catalogue

Cobe® 2991

FDA UDI

Class U (US FDA UDI)

by Terumo BCT, Inc..

Identity

Trade Name
COBE® 2991 FDA UDI
Generic Name
Blood transfer set FDA UDI
Device Name
Coupler Adaptor FDA UDI
Model / Reference
90904 FDA UDI
Description
Coupler Adaptor FDA UDI

Identifiers

Catalog Number
90904 FDA UDI
Primary DI / UDI-DI
05020583909045 FDA UDI
510(k) Number
K893962 FDA UDI
FDA Product Code
LKN FDA UDI
GMDN Term
Blood transfer set FDA UDI

Classification

Device Class
U 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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Blood transfer set

Cobe® 2991 by Terumo BCT, Inc.. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blood transfer set.

Cleared under the same submission

K893962 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Terumo BCT, Inc..

Sources (1)

  • FDA UDI 86b12bf4-2616-465f-a786-8ec9f2315e42 37 fields · synced May 30, 2026