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Silente, Intersurgical EcoLite, pediatric adjustable venturi mask kit
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Silente, Intersurgical EcoLite, pediatric adjustable venturi mask kit FDA UDI
- Generic Name
- Rebreathing oxygen face mask FDA UDI
- Device Name
- Silente, Intersurgical EcoLite, pediatric adjustable venturi mask kit with universal connector tube, 1.8m FDA UDI
- Model / Reference
- 11386100 FDA UDI
- Description
- Silente, Intersurgical EcoLite, pediatric adjustable venturi mask kit with universal connector tube, 1.8m FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816472021821 FDA UDI
- FDA Product Code
- BYG FDA UDI
- GMDN Term
- Rebreathing 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
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Rebreathing oxygen face mask
Silente, Intersurgical EcoLite, pediatric adjustable venturi mask kit by Intersurgical Incorporated — Class I — FDA UDI — listed in FDA GUDID
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Also classified as Rebreathing oxygen face mask.
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- ClasStar, GanzGesMask, NIV, AAV, L — Drägerwerk AG & Co. KGaA · Class IIa
- Venticaire Lite — FLEXICARE MEDICAL LIMITED · Class I
- Oro-Nasal Mask — HANS RUDOLPH, INC. · Class IIa
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 634309ea-0e8a-4338-86dc-be5c446de1d1 34 fields · synced May 30, 2026