Identity
- Trade Name
- BAIXIN FDA UDI
- Generic Name
- General-purpose syringe/needle FDA UDI
- Model / Reference
- 5ML22GSLIP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936018501311 FDA UDI
- 510(k) Number
- K083686 FDA UDI
- FDA Product Code
- FMF 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
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
Yes
FDA UDI
Ethylene Oxide FDA UDI
Category: General-purpose syringe/needle
Baixin by Anhui Kangda Medical Products Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose syringe/needle.
- 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
- 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
- CarePoint Precision — ALLISON MEDICAL, INC. · Class II
- CAINA — Jiangsu Caina Medical Co., Ltd · Class II
Cleared under the same submission
K083686 also covers:
- AQUILAVIE HEALTHCARE — Anhui Kangda Medical Products Co., Ltd.
- BAIXIN — Anhui Kangda Medical Products Co., Ltd.
- BAIXIN — Anhui Kangda Medical Products Co., Ltd.
- BAIXIN — Anhui Kangda Medical Products Co., Ltd.
- BAIXIN — Anhui Kangda Medical Products Co., Ltd.
- BAIXIN — Anhui Kangda Medical Products Co., Ltd.
- BAIXIN — Anhui Kangda Medical Products Co., Ltd.
- BAIXIN — Anhui Kangda Medical Products Co., Ltd.
- BAIXIN — Anhui Kangda Medical Products Co., Ltd.
- BAIXIN — Anhui Kangda Medical Products Co., Ltd.
- BAIXIN — Anhui Kangda Medical Products Co., Ltd.
- BAIXIN — Anhui Kangda Medical Products 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
- Anhui Kangda Medical Products Co., Ltd.
Sources (1)
- FDA UDI 404c0f81-6ae6-40a5-ae28-c19cea6b78dc 33 fields · synced Jun 8, 2026