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FecalSwab™

FDA UDI

Class I (US FDA UDI)

by Copan Italia Spa

Identity

Trade Name
FecalSwab™ FDA UDI
Generic Name
Rectal/faecal specimen collection kit FDA UDI
Device Name
FecalSwab™ Collection Kit FDA UDI
Model / Reference
220258 FDA UDI
Description
FecalSwab™ Collection Kit FDA UDI

Identifiers

Catalog Number
220258 FDA UDI
Primary DI / UDI-DI
38053326002190 FDA UDI
510(k) Number
K142094 FDA UDI
FDA Product Code
JSM FDA UDI
LIO FDA UDI
GMDN Term
Rectal/faecal specimen collection kit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.2390 FDA UDI
866.2900 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: Rectal/faecal specimen collection kit

FecalSwab™ by Copan Italia Spa — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rectal/faecal specimen collection kit.

Cleared under the same submission

K142094 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Copan Italia Spa

Sources (1)

  • FDA UDI 3fecfb8f-4cf8-40fd-92b3-3a5d71b68303 35 fields · synced Jun 1, 2026