Therapak

Basic Information

• Brand Name: Therapak
• Primary DI: 00810185250509
• Version / Model: ACSK38107
• Catalog Number: ACSK38107
• Company Name: Therapak LLC
• Labeler DUNS: 791071165
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 24
• Record Status: Published
• Publish Date: 2025-08-11
• Public Version: 1
• Public Version Date: 2025-08-19
• Public Version Status: New
• Public Device Record Key: 301c48a7-65df-40f2-941f-b7c0b07f934f

Device Description

Blood Alcohol Collection and Transport Kit (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: Yes
• 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
KST	System, Blood Collection, Vacuum-Assisted, Manual	Hematology	864.9125	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65859	Capillary blood collection set, professional	A collection of devices intended to be used by a healthcare professional at the point-of-care to collect a capillary blood sample from a patient for subsequent diagnostic testing or screening purposes. It typically includes a lancet and a blood collection device (consisting of a capillary tube and blood collection tube) and may also include gloves, gauze pads, alcohol pads and dressings. 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	00810185250516	GS1
Primary	00810185250509	GS1