Identity
- Trade Name
- SampLok® Adapter Cap 2 FDA UDI
- Generic Name
- Blood collection tube holder, single-use FDA UDI
- Device Name
- The SampLok® Adapter Cap has a Luer thread which facilitates attachment with commonly available multi-sample Luer adaptor; Intended to facilitate collection of blood sample into either culture bottles or vacuum tubes. It is a single use device. FDA UDI
- Model / Reference
- A100718 FDA UDI
- Description
- The SampLok® Adapter Cap has a Luer thread which facilitates attachment with commonly available multi-sample Luer adaptor; Intended to facilitate collection of blood sample into either culture bottles or vacuum tubes. It is a single use device. FDA UDI
Identifiers
- Catalog Number
- A100718 FDA UDI
- Primary DI / UDI-DI
- 09555240401304 FDA UDI
- 510(k) Number
- K000777 FDA UDI
- FDA Product Code
- JKA FDA UDI
- GMDN Term
- Blood collection tube holder, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1675 FDA UDI
- Commercial Distribution
- Not 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
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
No
FDA UDI
SampLok® Adapter Cap 2 by Itl Asia Pacific Sdn. Bhd. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Itl Asia Pacific Sdn. Bhd.
Sources (1)
- FDA UDI b989fee3-aeec-4c4e-924c-bc678982e2b4 38 fields · synced May 30, 2026