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Silente, Intersurgical Ecolite™, Adult, Adjustable Venturi Mask Kit And Tube
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- SILENTE, INTERSURGICAL ECOLITE™, ADULT, ADJUSTABLE VENTURI MASK KIT AND TUBE FDA UDI
- Generic Name
- Venturi oxygen face mask FDA UDI
- Device Name
- SILENTE, INTERSURGICAL ECOLITE™, ADULT, ADJUSTABLE VENTURI MASK KIT AND TUBE WITH UNIVERSAL CONNECTOR, 1.8M FDA UDI
- Model / Reference
- 1137016 FDA UDI
- Description
- SILENTE, INTERSURGICAL ECOLITE™, ADULT, ADJUSTABLE VENTURI MASK KIT AND TUBE WITH UNIVERSAL CONNECTOR, 1.8M FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05030267157877 FDA UDI
- FDA Product Code
- BYG FDA UDI
- GMDN Term
- Venturi oxygen face mask FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5580 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Venturi oxygen face mask
Silente, Intersurgical Ecolite™, Adult, Adjustable Venturi Mask Kit And Tube by Intersurgical Incorporated — Class I — FDA UDI — listed in FDA GUDID
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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
- Intersurgical Incorporated
Sources (1)
- FDA UDI e826925f-fdec-4672-8508-6b1fa8843d92 34 fields · synced May 30, 2026