Identity
- Trade Name
- Kurin Blood Culture Collection Set FDA UDI
- Generic Name
- Blood collection set, invasive FDA UDI
- Device Name
- Needle Gauge/Type = 23/Standard, Lock Type = Non-Vented, Set Length = 12", Blood Collection Holder = Short Saf-T Adapter FDA UDI
- Model / Reference
- TJ-123 EUDAMEDFDA UDI
- Description
- Needle Gauge/Type = 23/Standard, Lock Type = Non-Vented, Set Length = 12", Blood Collection Holder = Short Saf-T Adapter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20857606008312 EUDAMED00857606008318 FDA UDI
- Basic UDI-DI
- B-20857606008312 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
Category: Hypodermic needle, single-use
Tj-123 by Kurin, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hypodermic needle, single-use.
- Monoject — Cardinalhealth · Class II
- Pinpoint GT — Bard Access Systems, Inc. · Class II
- Safety Needle — Jiangsu Micsafe Medical Technology Co., Ltd · Class IIa
- Syringe w/Needle, Non-Toxic, 25G x 1", Luer Lock — Dynarex Corp. · Class II
- Yeso med — WUXI YUSHOU MEDICAL APPLIANCES CO., LTD. · Class II
- EasyTouch — MHC Medical Products · Class II
- STERiJECT TM — TSK LABORATORY, JAPAN · Class II
- Comfort EZ Pro — S.D.I. USA, INC. · Class II
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-20857606008312 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Kurin, Inc.
- EUDAMED SRN
- US-MF-000025001
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED d9e1bd79-67e9-44bb-863c-73e82febee24 61 fields · synced Jul 16, 2026
- FDA UDI 6da586db-6f54-46d4-b13e-e70bec1ebcfa 34 fields · synced May 30, 2026