Identity
- Trade Name
- Kurin Blood Culture Collection Set FDA UDI
- Generic Name
- Blood collection set, invasive FDA UDI
- Device Name
- Needle Gauge/Type = 21/Standard, Lock Type = Non-Vented, Set Length = 12", Blood Collection Holder = Short Saf-T Adapter FDA UDI
- Model / Reference
- TJ-121 EUDAMEDFDA UDI
- Description
- Needle Gauge/Type = 21/Standard, Lock Type = Non-Vented, Set Length = 12", Blood Collection Holder = Short Saf-T Adapter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20857606008329 EUDAMED00857606008271 FDA UDI
- Basic UDI-DI
- B-20857606008329 EUDAMED
- 510(k) Number
- K162233 FDA UDI
- FDA Product Code
- JKA FDA UDI
- EMDN Code
- A0101010101 HYPODERMIC SYRINGE NEEDLES, WITH SAFETY SYSTEMS EUDAMED
- GMDN Term
- Blood collection set, invasive FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1675 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Tj-121 by Kurin, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-20857606008329 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Kurin, Inc.
- EUDAMED SRN
- US-MF-000025001
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED d664640c-5b04-4962-9003-5b7f5a46c94f 61 fields · synced Jun 18, 2026
- FDA UDI 13912c5a-10de-4ac2-a1c0-6d79aa948c83 34 fields · synced May 29, 2026