Identity
- Trade Name
- CAINA FDA UDI
- Generic Name
- General-purpose syringe/needle FDA UDI
- Device Name
- 1 ml luer lock syringe with needle 25Gx1.The syringes are intended to inject fluids into or withdraw fluids from the body. FDA UDI
- Model / Reference
- 1ML LL 25GX1 FDA UDI
- Description
- 1 ml luer lock syringe with needle 25Gx1.The syringes are intended to inject fluids into or withdraw fluids from the body. FDA UDI
Identifiers
- Catalog Number
- SNL12510 FDA UDI
- Primary DI / UDI-DI
- 06971564465380 FDA UDI
- 510(k) Number
- K113091 FDA UDI
- FDA Product Code
- FMI 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 UDINeedle Gauge — 25 Gauge FDA UDILength — 1 Inch 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
Similar devices
Also classified as General-purpose syringe/needle.
- BAIXIN — Anhui Kangda Medical Products Co., Ltd. · Class II
- CarePoint Precision — ALLISON MEDICAL, INC. · Class II
- YI XIN Sterile Syringe For Single Use — Jiang Xi Sanxin Medtec Co., Ltd. · Class II
- Micsafe — Jiangsu Micsafe Medical Tehcnology Co., LTD. · Class II
- BAIXIN — Anhui Kangda Medical Products Co., Ltd. · Class II
- Azur Medical Company Inc. — Azur Medical Company, Inc. · Class II
- Custom Healthcare Systems Inc. — Manus Medical, LLC · Class II
- RELI® — MYCO MEDICAL SUPPLIES INC. · Class II
Cleared under the same submission
K113091 also covers:
- Monoject — Cardinalhealth
- Allergy Tray — Dynarex Corp.
- Syringe 3ml — GERI-GENTLE CORPORATION
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- CAINA — Jiangsu Caina Medical Co., Ltd
- CAINA — Jiangsu Caina Medical Co., Ltd
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
- Jiangsu Caina Medical Co., Ltd
Sources (1)
- FDA UDI 63b3d6a1-4d2c-4915-86f4-536751e81402 36 fields · synced May 30, 2026