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Quadralite, Anaesthetic Face Mask, Size 1, Infant, Grey Seal, No Hook Ring, 15m
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- QUADRALITE, ANAESTHETIC FACE MASK, SIZE 1, INFANT, GREY SEAL, NO HOOK RING, 15M FDA UDI
- Generic Name
- Anaesthesia face mask, single-use FDA UDI
- Device Name
- QUADRALITE, ANAESTHETIC FACE MASK, SIZE 1, INFANT, GREY SEAL, NO HOOK RING, 15M (REPLACES TRADITIONAL MASK SIZE 0-1) FDA UDI
- Model / Reference
- 7191000 FDA UDI
- Description
- QUADRALITE, ANAESTHETIC FACE MASK, SIZE 1, INFANT, GREY SEAL, NO HOOK RING, 15M (REPLACES TRADITIONAL MASK SIZE 0-1) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05030267079032 FDA UDI
- FDA Product Code
- BSJ FDA UDI
- GMDN Term
- Anaesthesia face mask, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5550 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: Anaesthesia face mask, single-use
Quadralite, Anaesthetic Face Mask, Size 1, Infant, Grey Seal, No Hook Ring, 15m by Intersurgical Incorporated — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Anaesthesia face mask, single-use.
- Ventlab — Ventlab Corp. · Class I
- Resp-O2 Air Cushion Mask with Valve, Size #1, Neonate/Infant — Dynarex Corp. · Class I
- Anesthesia Mask — XIAMEN COMPOWER MEDICAL TECH. CO., LTD. · Class IIa
- Vital Signs™ — Airlife, Inc. · Class I
- Ventlab — Ventlab Corp. · Class I
- Anesthesia mask — Henan Tuoren Medical Device Co., Ltd · Class IIa
- Anesthesia Mask — XIAMEN COMPOWER MEDICAL TECH. CO., LTD. · Class IIa
- King Mask — Ambu A/S · 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 |
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Manufacturer
- Manufacturer
- Intersurgical Incorporated
Sources (1)
- FDA UDI 75edd842-e66c-4834-8fef-ae201cbe260b 34 fields · synced May 30, 2026