← Back to catalogue
M-21223
EUDAMEDFDA 510(k)FDA UDIClass IIa (EU MDR)
Ref M-21223510(k) K191832Ref D-21223Ref D-11221Ref T-21223
by Kurin, Inc.
Identity
- Trade Name
- Kurin EUDAMEDKurin 21 Gauge, Standard Needle w/12" Tubing, BD Vacutainer FDA UDIKurin 23 Gauge, Push Button Needle w/12" Tubing, Saf-T Holder Device FDA UDI
- Generic Name
- Blood collection set, invasive FDA UDI
- Device Name
- Kurin Blood Culture Collection Set EUDAMED
- Model / Reference
- M-21223 EUDAMEDD-11221 EUDAMEDFDA UDIT-21223 EUDAMEDFDA UDID-21223 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 20857606008084 EUDAMED20857606008039 EUDAMED20857606008008 EUDAMED20857606008138 EUDAMED00857606008004 FDA UDI00857606008134 FDA UDI
- Basic UDI-DI
- B-20857606008084 EUDAMEDB-20857606008039 EUDAMEDB-20857606008008 EUDAMEDB-20857606008138 EUDAMED
- FDA Product Code
- JKA FDA 510(k)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 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 862.1675 FDA 510(k)
- Regulation Number
- 862.1675 FDA 510(k)FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- 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
M-21223 by Kurin, Inc. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k), 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
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191832 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-20857606008084 | Class IIa | Active |
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 (7)
- EUDAMED 4ff599fc-8adb-4e4b-9ddf-0a7ad3097286 61 fields · synced Aug 1, 2026
- FDA 510(k) K191832 24 fields · synced May 18, 2026
- FDA UDI ca216075-16cd-46ab-877b-3a005b393236 33 fields · synced May 30, 2026
- FDA UDI eb5dc1ad-fd01-4bae-aa3e-3e9d7535b54e 33 fields · synced May 30, 2026
- EUDAMED 087546f9-fc6c-45fb-b17a-6c570a858a8c 61 fields · synced Jul 12, 2026
- EUDAMED 40691027-39f8-422a-b520-7f6016fa9885 61 fields · synced Jul 21, 2026
- EUDAMED a29ea041-6a21-400d-b4e1-de520365f885 61 fields · synced Aug 1, 2026