Identity
- Trade Name
- SINYA FDA UDI
- Generic Name
- Non-fixed medical gas cylinder regulator FDA UDI
- Device Name
- 50PSI GAS REGULATOR, CGA950, MEDICAL AIR, DISS OUTLET FDA UDI
- Model / Reference
- PR950 FDA UDI
- Description
- 50PSI GAS REGULATOR, CGA950, MEDICAL AIR, DISS OUTLET FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06977645350477 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
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
No
Category: Non-fixed medical gas cylinder regulator
The SINYA regulator is a high-performance, industrial-grade gas regulator designed for medical and non-medical applications. With its unique CGA950 certification and PR950 version number, it ensures compliance with international standards for safe and efficient gas supply. This device features a reliable safety relief valve, adjustable working pressure, and a durable construction suitable for various environments.
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Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Danyang Xinya Valve Co., Ltd.
Sources (1)
- FDA UDI 8dc24ce6-3bc0-4ea2-97ce-d95c72648234 33 fields · synced Jul 17, 2026