Transystem™

FDA UDI

Class I (US FDA UDI)

by Copan Italia Spa

Identity

Trade Name: Transystem™ FDA UDI
Generic Name: General specimen collection kit FDA UDI
Device Name: TRANSYSTEM AMIES W/O CH PLASTIC APPLICATOR RAYON TIPPED FDA UDI
Model / Reference: 108C.USE FDA UDI
Description: TRANSYSTEM AMIES W/O CH PLASTIC APPLICATOR RAYON TIPPED FDA UDI

Identifiers

Catalog Number: 108C.USE FDA UDI
Primary DI / UDI-DI: 28053326000588 FDA UDI
510(k) Number: K972448 FDA UDI
FDA Product Code: JSL FDA UDI
GMDN Term: General specimen collection kit FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 866.2390 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: General specimen collection kit

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

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Cleared under the same submission

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: Copan Italia Spa

Sources (1)

FDA UDI 9a3d9bf1-73c9-47d3-bd72-6669b7c540ca 35 fields · synced Jun 8, 2026