Therapak

Basic Information

• Brand Name: Therapak
• Primary DI: 00810185250301
• Version / Model: ACSK39449
• Catalog Number: ACSK39449
• Company Name: Therapak LLC
• Labeler DUNS: 158388061
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2025-08-04
• Public Version: 1
• Public Version Date: 2025-08-12
• Public Version Status: New
• Public Device Record Key: e0a2bbee-60cc-4329-9046-1f17853b3336

Device Description

Split Foil Top Specimen Collection Kit (CS/100)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MPQ	Container, Specimen, Urine, Drugs Of Abuse, Over The Counter	Pathology	864.3260	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38868	Drug-testing specimen collection kit IVD	A covered receptacle and other associated materials/tools, available for use in the home and clinical settings, intended to be used for the collection, and preservation and/or transport, of a clinical specimen that may include hair, urine, sweat, or saliva suitable for drug testing and/or other in vitro diagnostic investigation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00810185250318	GS1
Primary	00810185250301	GS1