Therapak ACSK40005

GUDID 00810185250110

Urine Collection Kit Bag (CS/100)

Therapak LLC

Drug-testing specimen collection kit IVD

• Primary Device ID: 00810185250110
• NIH Device Record Key: 4b88a2f2-b333-445e-8ba7-83daf5b90968
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Therapak
• Version Model Number: ACSK40005
• Catalog Number: ACSK40005
• Company DUNS: 158388061
• Company Name: Therapak LLC
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810185250103 [Primary]
GS1	00810185250110 [Unit of Use]

FDA Product Code

• MPQ: Container, Specimen, Urine, Drugs Of Abuse, Over The Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-12
• Device Publish Date: 2025-08-04

On-Brand Devices [Therapak]

• 07312058462932: Stone Screen Collection Cup - 12/Pack
• 07312058462895: Urine Collection Kit Bag (CS/100)
• 07312058462864: Generic Split 45ml Collection Kit
• 07312058462796: 180ml Collection Cup, Individually Wrapped w/temp strip
• 07312058462789: Split 45 mL Vial Box Kit
• 07312058462772: Split Foil Top Specimen Collection Kit
• 07312058462758: Single Foil Top Specimen Collection Kit
• 07312058462710: 16 Vial Prostate Biopsy Kit (CS/20)
• 07312058462598: 240 mL Beaker Style Collection Cup with Temperature Strip
• 07312058462581: 240 mL Collection Cup, PP, Non-Sterile
• 07312058462543: 45 mL Tamper Evident Vial
• 07312058462536: 45 mL Tamper Evident Vial
• 07312058462499: 6.5oz Beaker w/Dual Temp Strip
• 07312058462444: 6.5 oz. Sleeved Beaker Style Collection Cup, PP, Non-Sterile
• 07312058462413: Single 45mL Vial Bag Kit 100/case
• 07312058462468: StoneScreen Collection Cup
• 07312058462666: Generic Blood Alcohol Collection and Transport Kit (CS/24)
• 00810185250059: Stone Screen Collection Cup - 12/Pack
• 00810185250592: 6.5oz Beaker w/Dual Temp Strip (CS/500)
• 00810185250578: 240 mL Beaker Style Collection Cup with Temperature Strip (CS/500)
• 00810185250394: 16 Vial Prostate Biopsy Kit (CS/20)
• 00810185250332: Single Foil Top Specimen Collection Kit (CS/100)
• 00810185250318: Split Foil Top Specimen Collection Kit (CS/100)
• 00810185250295: Split 45 mL Vial Box Kit (CS/48)
• 00810185250271: 180ml Collection Cup, Individually Wrapped w/temp strip (CS/100)
• 00810185250172: Generic Split 45ml Collection Kit (CS/100)
• 00810185250110: Urine Collection Kit Bag (CS/100)
• 00810185250677: Drug Screen Kit (CS/48)
• 00810185250653: 90x53 container w/Temp Strip (CS/100)
• 00810185250615: 2 Litre Histology Container (CS/20)
• 00810185250554: Urine Cytology/FISH Testing Kit (CS/30)
• 00810185250530: Generic 12-Vial Prostate Biopsy Transport Kit (CS/30)
• 00810185250516: Blood Alcohol Collection and Transport Kit (CS/24)
• 00810185250493: Therapak Acetic Acid 24 Hour Collection (CS/24)
• 00810185250479: Hydrochloric Acid 24 Hour Urine Collection Kit (CS/24)
• 00810185250455: 8-Vial Prostate Biopsy Transport Kit, 30/case
• 00810185250431: 14 Vial Prostate Biopsy Transport Kit (CS/20)
• 00810185250370: GI Biopsy Kit, 2 Vial 20/CS
• 00810185250356: StoneScreen Collection and Transport Kit (CS/16)
• 00810185250257: Split Collection Kit (CS/50)
• 00810185250233: Single 45mL Bulk Supply Kit (CS/100)
• 00810185250219: 8 Liter Histology Bucket (CS/10)
• 00810185250196: Flow Cytometry / Molecular Pathology Collection/ Transport Kit (CS/30)
• 00810185250158: 90mL Cup w/Evidence Seal (CS/100)
• 00810185250134: Drug Screen Kit Shipping System (CS/100)
• 00810185250097: Urine Collection Kit Bag (CS/100)
• 00810185250073: Split Collection Kit (CS/50)
• 00810185250035: Single 45mL Vial Bag Kit 100/case
• 00810185250011: Therapak 5 Liter Container (CS/10)