Identity
- Trade Name
- SampLok® Sampling Kit 35mL FDA UDI
- Generic Name
- Blood/blood culture specimen transfer spike IVD, manual FDA UDI
- Device Name
- SampLok® Sampling Kit (SSK): SSK-Mk3-35mL is used to transfer samples from blood bags or other containers with sterile docking compatible tubing to vacuum containers for laboratory tests. FDA UDI
- Model / Reference
- A100752 FDA UDI
- Description
- SampLok® Sampling Kit (SSK): SSK-Mk3-35mL is used to transfer samples from blood bags or other containers with sterile docking compatible tubing to vacuum containers for laboratory tests. FDA UDI
Identifiers
- Catalog Number
- A100752 FDA UDI
- Primary DI / UDI-DI
- 09555240403865 FDA UDI
- FDA Product Code
- KSS FDA UDI
- GMDN Term
- Blood/blood culture specimen transfer spike IVD, manual FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.9050 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
SampLok® Sampling Kit 35mL by Itl Asia Pacific Sdn. Bhd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Itl Asia Pacific Sdn. Bhd.
Sources (1)
- FDA UDI dc80f72f-4f50-4616-b1f1-e76276a3f286 38 fields · synced Jun 8, 2026