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Kurin 21 Gauge, Standard Needle w/12" Tubing, BD Vacutainer
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref D-11221
by Kurin, Inc.
Identity
- Trade Name
- Kurin EUDAMEDKurin 21 Gauge, Standard Needle w/12" Tubing, BD Vacutainer FDA UDI
- Generic Name
- Blood collection set, invasive FDA UDI
- Device Name
- Kurin Blood Culture Collection Set EUDAMED
- Model / Reference
- D-11221 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 20857606008008 EUDAMED00857606008004 FDA UDI
- Basic UDI-DI
- B-20857606008008 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
Kurin 21 Gauge, Standard Needle w/12" Tubing, BD Vacutainer by Kurin, Inc. — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
K162233 also covers:
- Kurin 21 Gauge, Push Button Needle w/12" Tubing, BD Vacutainer — Kurin, Inc.
- Kurin 21 Gauge, Push Button Needle w/12" Tubing, BioMerieux Shield — Kurin, Inc.
- Kurin 23 Gauge, Push Button Needle w/12" Tubing, BioMerieux Shield — Kurin, Inc.
- Kurin 23 Gauge, Push Button Needle w/12" Tubing, Saf-T Holder Device — Kurin, Inc.
- Kurin 23 Gauge, Standard Needle w/12" Tubing, BioMerieux Shield — Kurin, Inc.
- Kurin Blood Culture Collection Set — Kurin, Inc.
- Kurin Blood Culture Collection Set — Kurin, Inc.
- Kurin Blood Culture Collection Set — Kurin, Inc.
- Kurin PIV (Peripheral IntraVenous) Connection, w/ BioMerieux Shield — Kurin, Inc.
- Kurin PIV (Peripheral IntraVenous) Connection, w/BD Vacutainer — Kurin, Inc.
- Kurin PIV Connection, w/ BD Vacutainer & Pressure-Rated Extension Set — Kurin, Inc.
- Kurin PIV Connection, w/ BioMerieux Shield & Pressure-Rated Extension Set — Kurin, Inc.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Kurin, Inc.
Sources (2)
- FDA UDI ca216075-16cd-46ab-877b-3a005b393236 33 fields · synced Oct 7, 2026
- EUDAMED 40691027-39f8-422a-b520-7f6016fa9885 61 fields · synced Jul 21, 2026