Identity
- Trade Name
- ECLERIS NIV HELMET FDA UDI
- Generic Name
- In-line CPAP set, non-nebulizing FDA UDI
- Device Name
- ECLERIS NIV HELMET FDA UDI
- Model / Reference
- R00 FDA UDI
- Description
- ECLERIS NIV HELMET FDA UDI
Identifiers
- Catalog Number
- U1VNI1001 FDA UDI
- Primary DI / UDI-DI
- B366U1VNI1001 FDA UDI
- FDA Product Code
- FOG FDA UDI
- GMDN Term
- In-line CPAP set, non-nebulizing FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5700 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
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: In-line CPAP set, non-nebulizing
Ecleris Niv Helmet by Ecleris — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Ecleris
Sources (1)
- FDA UDI c4c2e4da-cf83-481f-be9a-29bb9cb8fff8 36 fields · synced Jun 8, 2026