← Back to catalogue
Silente, Intersurgical Ecolite, Paediatric, Adjustable Venturi Mask Kit
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- SILENTE, INTERSURGICAL ECOLITE, PAEDIATRIC, ADJUSTABLE VENTURI MASK KIT FDA UDI
- Generic Name
- Venturi oxygen face mask FDA UDI
- Device Name
- SILENTE, INTERSURGICAL ECOLITE, PAEDIATRIC, ADJUSTABLE VENTURI MASK KIT WITH TUBE, 1.8M FDA UDI
- Model / Reference
- 1138015 FDA UDI
- Description
- SILENTE, INTERSURGICAL ECOLITE, PAEDIATRIC, ADJUSTABLE VENTURI MASK KIT WITH TUBE, 1.8M FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05030267105021 FDA UDI
- FDA Product Code
- BYF FDA UDI
- GMDN Term
- Venturi oxygen face mask FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5600 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
Category: Venturi oxygen face mask
Silente, Intersurgical Ecolite, Paediatric, Adjustable Venturi Mask Kit by Intersurgical Incorporated — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Venturi oxygen face mask.
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC · Class I
- Mask ventkit O2Star adjust M/L — Drägerwerk AG & Co. KGaA · Class I
- Pediatric Elongated Venturi Mask Kit — WESTMED, INC. · Class I
- Venticaire Lite — FLEXICARE MEDICAL LIMITED · Class I
- Venticaire Lite — FLEXICARE MEDICAL LIMITED · Class I
- Venticaire Lite — FLEXICARE MEDICAL LIMITED · Class I
- Venticaire Lite — FLEXICARE MEDICAL LIMITED · Class I
- Venticaire Lite — FLEXICARE MEDICAL LIMITED · Class I
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
- Intersurgical Incorporated
Sources (1)
- FDA UDI 9741ce2d-b37f-479c-bb8a-518c2f1bfd5d 34 fields · synced May 30, 2026