Identity
- Trade Name
- CAINA FDA UDI
- Generic Name
- Hypodermic needle, single-use FDA UDI
- Device Name
- Safety needle 25G*5/8.The Safety Needle is intended for use with a luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle stick.The safety needle contained in a sterility FDA UDI
- Model / Reference
- 25G*5/8-01 FDA UDI
- Description
- Safety needle 25G*5/8.The Safety Needle is intended for use with a luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle stick.The safety needle contained in a sterility FDA UDI
Identifiers
- Catalog Number
- CA253 FDA UDI
- Primary DI / UDI-DI
- 06971564465106 FDA UDI
- 510(k) Number
- K193526 FDA UDI
- FDA Product Code
- FMI FDA UDIMEG FDA UDIFMF FDA UDI
- GMDN Term
- Hypodermic needle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 FDA UDI880.5860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 25 Gauge FDA UDILength — 0.625 Inch FDA UDI
Category: Hypodermic needle, single-use
Caina by Jiangsu Caina Medical Co., Ltd — Class II — FDA UDI — listed in 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
Cleared under the same submission
K193526 also covers:
- BH Supplies — ANREL DISTRIBUTION LLC
- BH Supplies — ANREL DISTRIBUTION LLC
- BH Supplies — ANREL DISTRIBUTION LLC
- AMG — ARROW MEDSOURCE GROUP LIMITED
- AMG — ARROW MEDSOURCE GROUP LIMITED
- AMG — ARROW MEDSOURCE GROUP LIMITED
- AMG — ARROW MEDSOURCE GROUP LIMITED
- AMG — ARROW MEDSOURCE GROUP LIMITED
- AMG — ARROW MEDSOURCE GROUP LIMITED
- NEEDLES 23x1 — GERI-GENTLE CORPORATION
- NEEDLES 25x1 — GERI-GENTLE CORPORATION
- NEEDLES 25x5/8 — GERI-GENTLE CORPORATION
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 |
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Manufacturer
- Manufacturer
- Jiangsu Caina Medical Co., Ltd
Sources (1)
- FDA UDI e0d12627-4df7-4ba5-b768-f10e1929ed7c 36 fields · synced May 30, 2026