Identity
- Trade Name
- DORA FDA UDI
- Generic Name
- Haemodialysis needle FDA UDI
- Model / Reference
- BAIN-A.V.F-003SG FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06948082700613 FDA UDI
- FDA Product Code
- FIE FDA UDI
- GMDN Term
- Haemodialysis needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5540 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
Yes
FDA UDI
Category: Haemodialysis needle
Dora by Bain Medical Equipment (Guangzhou) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haemodialysis needle.
- masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS — NxStage Medical, Inc. · Class II
- Medisystems OneSite dual lumen needle with masterguard — Medisystems Corp. · Class II
- Medisystems OneSite dual lumen buttonhole needle with steripick — Medisystems Corp. · Class II
- JMS SYSLOC MINI AVF NEEDLE SET — JMS SINGAPORE PTE LTD · Class II
- Nipro SafeTouch TULIP Safety Fistula Needle — NIPRO MEDICAL CORPORATION · Class II
- ButtonHole with SteriPick NEEDLE SET — NxStage Medical, Inc. · Class II
- JMS HARMONY A.V.FISTULA NEEDLE SET — JMS SINGAPORE PTE LTD · Class II
- ButtonHole with SteriPick TWINPACK+ NEEDLE SET — NxStage Medical, Inc. · Class II
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
- Bain Medical Equipment (Guangzhou) Co., Ltd.
Sources (1)
- FDA UDI 91d64f27-0759-4448-93a3-0a7d5dae854b 32 fields · synced May 30, 2026