Identity
- Trade Name
- SampLok® Adapter Cap Kit EUDAMEDFDA UDI
- Generic Name
- Blood collection tube holder, single-use FDA UDI
- Device Name
- Adapter Cap EUDAMEDSampLok® Adaptor Cap Kit (SampLok® Adaptor Cap, clear, assembled with PP Luer, bulk, non-sterile); It is intended to facilitate collection of blood samples into either a culture bottle or standard vacuum blood tubes. FDA UDI
- Model / Reference
- A100704 EUDAMEDFDA UDI
- Description
- SampLok® Adaptor Cap Kit (SampLok® Adaptor Cap, clear, assembled with PP Luer, bulk, non-sterile); It is intended to facilitate collection of blood samples into either a culture bottle or standard vacuum blood tubes. FDA UDI
Identifiers
- Catalog Number
- A100704 FDA UDI
- Primary DI / UDI-DI
- 19555240400199 EUDAMEDFDA UDI
- Basic UDI-DI
- 955524040ACNSED EUDAMED
- 510(k) Number
- K021941 FDA UDI
- FDA Product Code
- FMI FDA UDIJKA FDA UDI
- EMDN Code
- W0501010180 VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Blood collection tube holder, single-use FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5570 FDA UDI862.1675 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
SampLok® Adapter Cap Kit by Itl Asia Pacific Sdn. Bhd. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 955524040ACNSED | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- ITL Asia Pacific Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000001570
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 6b6085a8-78d3-4b9c-8a5e-ee8e6a20a82b 61 fields · synced Jun 19, 2026
- FDA UDI b8a03b62-6a0d-4a22-a367-e05e9bc78749 37 fields · synced May 30, 2026