Therapak

Basic Information

• Brand Name: Therapak
• Primary DI: 07312058462673
• Version / Model: ACSK38533
• Catalog Number: ACSK38533
• Company Name: Therapak LLC
• Labeler DUNS: 791071165
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-21
• Public Version: 1
• Public Version Date: 2022-12-29
• Public Version Status: New
• Public Device Record Key: 35314cb1-58ff-4b1a-8d8c-2501d7079ac4

Device Description

Therapak Acetic Acid 24 Hour Collection (CS/24)

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LDW	Fixative, Acid Containing	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57917	24-hour urine specimen container IVD, preservative	A capped receptacle, typically 2 to 4 litres, containing one or multiple preservatives [e.g., boric acid (H3BO3), hydrochloric acid (HCl), sodium carbonate (Na2CO3), sulphuric acid (H2SO4)] and intended to be used for the collection, preservation, and transport of urine collected over a 24-hour period for analysis 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
Primary	07312058462673	GS1