Fisherbrand

FDA UDI

Class I (US FDA UDI)

by Fisher Scientific Company L.l.c.

Identity

Trade Name: Fisherbrand FDA UDI
Generic Name: Rectal/faecal specimen collection kit FDA UDI
Device Name: SPECIMEN COLLECTION SYST 60/CS FDA UDI
Model / Reference: 02 544 208 FDA UDI
Description: SPECIMEN COLLECTION SYST 60/CS FDA UDI

Identifiers

Catalog Number: 02544208 FDA UDI
Primary DI / UDI-DI: 00613647005958 FDA UDI
FDA Product Code: KDT 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Rectal/faecal specimen collection kit

Fisherbrand by Fisher Scientific Company L.l.c. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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AmerisourceBergen — BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY · Class I
AmerisourceBergen — BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY · Class I
FecalSwab™ — COPAN ITALIA SPA · Class I
FecalSwab® — COPAN ITALIA SPA · Class I
Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Fisher Scientific Company L.l.c.

Sources (1)

FDA UDI c7f7923e-7fce-46ba-9079-2790d0fb7ff4 35 fields · synced May 30, 2026