Identity
- Trade Name
- CAINA FDA UDI
- Generic Name
- General-purpose syringe/needle FDA UDI
- Device Name
- The Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin. FDA UDI
- Model / Reference
- 1ml 25G*1 FDA UDI
- Description
- The Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin. FDA UDI
Identifiers
- Catalog Number
- SPN102510 FDA UDI
- Primary DI / UDI-DI
- 06971564465618 FDA UDI
- 510(k) Number
- K192551 FDA UDI
- FDA Product Code
- MEG FDA UDIFMF FDA UDI
- GMDN Term
- General-purpose syringe/needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 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
Similar devices
Also classified as General-purpose syringe/needle.
- BAIXIN — Anhui Kangda Medical Products Co., Ltd. · Class II
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- 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
K192551 also covers:
- CAINA — Jiangsu Caina Medical Co., Ltd
- CAINA — Jiangsu Caina Medical Co., Ltd
- CAINA — Jiangsu Caina Medical Co., Ltd
- Metier — Jiangsu Caina Medical Co., Ltd
- Metier — Jiangsu Caina Medical Co., Ltd
- Medline — MEDLINE INDUSTRIES, INC.
- Ceros — RHINO MEDICAL SUPPLY INC
- Ceros — RHINO MEDICAL SUPPLY INC
- Ceros — RHINO MEDICAL SUPPLY INC
- Ceros — RHINO MEDICAL SUPPLY INC
- Ceros — RHINO MEDICAL SUPPLY 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
- Jiangsu Caina Medical Co., Ltd
Sources (1)
- FDA UDI 3f25599e-bb6a-4eb3-89f5-9a1717c135ac 36 fields · synced Jun 8, 2026