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Therapak

FDA UDI

Class I (US FDA UDI)

by Therapak LLC

Identity

Trade Name
Therapak FDA UDI
Generic Name
Drug-testing urine specimen container IVD FDA UDI
Device Name
180ml Collection Cup, Individually Wrapped w/temp strip (CS/100) FDA UDI
Model / Reference
ACSK39473 FDA UDI
Description
180ml Collection Cup, Individually Wrapped w/temp strip (CS/100) FDA UDI

Identifiers

Catalog Number
ACSK39473 FDA UDI
Primary DI / UDI-DI
00810185250264 FDA UDI
FDA Product Code
MPQ FDA UDI
GMDN Term
Drug-testing urine specimen container IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.3260 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

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Drug-testing urine specimen container IVD

Therapak by Therapak LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Drug-testing urine specimen container IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Therapak LLC

Sources (1)

  • FDA UDI 0c9ed75e-92bc-45e3-b50f-245c73a2110d 34 fields · synced May 30, 2026