← Back to catalogue

AmerisourceBergen

FDA UDI

Class I (US FDA UDI)

by Bp Pharmaceuticals Laboratories Unlimited Company

Identity

Trade Name
AmerisourceBergen FDA UDI
Generic Name
Rectal/faecal specimen collection kit FDA UDI
Device Name
Fecal Diagnostic Kit Refill, Disposable, Non-sterile FDA UDI
Model / Reference
11504 FDA UDI
Description
Fecal Diagnostic Kit Refill, Disposable, Non-sterile FDA UDI

Identifiers

Primary DI / UDI-DI
00368001115049 FDA UDI
FDA Product Code
NNK FDA UDI
GMDN Term
Rectal/faecal specimen collection kit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.3250 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

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Rectal/faecal specimen collection kit

AmerisourceBergen by Bp Pharmaceuticals Laboratories Unlimited Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rectal/faecal specimen collection kit.

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
Bp Pharmaceuticals Laboratories Unlimited Company

Sources (1)

  • FDA UDI 9c1fcf6b-e1f2-4f5f-8454-494cba70aec3 33 fields · synced May 30, 2026