← Back to catalogue

Therapak

FDA UDI

Class I (US FDA UDI)

by Therapak LLC

Identity

Trade Name
Therapak FDA UDI
Generic Name
24-hour urine specimen container IVD, preservative FDA UDI
Device Name
Hydrochloric Acid 24 Hour Urine Collection Kit (CS/24) FDA UDI
Model / Reference
ACSK38534 FDA UDI
Description
Hydrochloric Acid 24 Hour Urine Collection Kit (CS/24) FDA UDI

Identifiers

Catalog Number
ACSK38534 FDA UDI
Primary DI / UDI-DI
00810185250462 FDA UDI
FDA Product Code
LDW FDA UDI
GMDN Term
24-hour urine specimen container IVD, preservative FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.4010 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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: 24-hour urine specimen container IVD, preservative

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

Similar devices

Also classified as 24-hour urine specimen container IVD, preservative.

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
Therapak LLC

Sources (1)

  • FDA UDI 10d4495e-2b65-4248-9fe2-87e6e9e98318 34 fields · synced May 30, 2026