Identity
- Trade Name
- Therapak FDA UDI
- Generic Name
- Capillary blood collection set, professional FDA UDI
- Device Name
- Generic Blood Alcohol Collection and Transport Kit (CS/24) FDA UDI
- Model / Reference
- ACSK38107 FDA UDI
- Description
- Generic Blood Alcohol Collection and Transport Kit (CS/24) FDA UDI
Identifiers
- Catalog Number
- ACSK38107 FDA UDI
- Primary DI / UDI-DI
- 07312058462666 FDA UDI
- FDA Product Code
- KST FDA UDI
- GMDN Term
- Capillary blood collection set, professional FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.9125 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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: Capillary blood collection set, professional
Therapak by Therapak LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Capillary blood collection set, professional.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Therapak LLC
Sources (1)
- FDA UDI fcf2db43-16e0-4125-86bb-f74c50ea1673 34 fields · synced May 30, 2026