Identity
- Trade Name
- CAINA FDA UDI
- Generic Name
- General-purpose syringe/needle FDA UDI
- Device Name
- Syringe with safety needle 1ml 23Gx1".The Syringe with Safety Needle is intended for use in the 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 syringe with safety needle contained in a sterility maintenance package. FDA UDI
- Model / Reference
- 1ml LL 23G*1-02 FDA UDI
- Description
- Syringe with safety needle 1ml 23Gx1".The Syringe with Safety Needle is intended for use in the 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 syringe with safety needle contained in a sterility maintenance package. FDA UDI
Identifiers
- Catalog Number
- CN12310 FDA UDI
- Primary DI / UDI-DI
- 06971564465205 FDA UDI
- 510(k) Number
- K193526 FDA UDI
- FDA Product Code
- FMI FDA UDIMEG FDA UDIFMF FDA UDI
- GMDN Term
- General-purpose syringe/needle 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
- Total Volume — 1 Milliliter FDA UDI
Category: General-purpose syringe/needle
Caina by Jiangsu Caina Medical Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General-purpose syringe/needle.
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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 0aba8c80-3908-492d-a7c0-2eb30098e2c9 36 fields · synced Jun 1, 2026