Identity
- Trade Name
- SINYA FDA UDI
- Generic Name
- Non-fixed medical gas cylinder regulator FDA UDI
- Model / Reference
- SR540-25D FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06977645350071 FDA UDI
- FDA Product Code
- CAN FDA UDI
- GMDN Term
- Non-fixed medical gas cylinder regulator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.2700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Non-fixed medical gas cylinder regulator
Sinya by Danyang Xinya Valve Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-fixed medical gas cylinder regulator.
- Ohio — Ohio Medical LLC · Class I
- Patient Loading Utility System (PLUS) — LIFEPORT, LLC. · Class I
- CarboJet® CO2 Bone Lavage System — Kinamed, Inc. · Class II
- Ohio — Ohio Medical LLC · Class I
- Patient Loading Utility System (PLUS) — LIFEPORT, LLC. · Class I
- Ohio — Ohio Medical LLC · Class I
- Ohio — Ohio Medical LLC · Class I
- CarboJet® CO2 Bone Lavage System — Kinamed, 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Danyang Xinya Valve Co., Ltd.
Sources (1)
- FDA UDI 2f354ea3-dcc7-450d-a6a4-80914cb8ec31 32 fields · synced May 30, 2026