Identity
- Trade Name
- Sharn Inc FDA UDI
- Generic Name
- Anaesthesia face mask, reusable FDA UDI
- Device Name
- ENDOMASK ELITE,SILICONE REUSE LARYNGEAL MASK,SIZE 3, 5/PK FDA UDI
- Model / Reference
- LMM-280030 FDA UDI
- Description
- ENDOMASK ELITE,SILICONE REUSE LARYNGEAL MASK,SIZE 3, 5/PK FDA UDI
Identifiers
- Catalog Number
- LMM-280030 FDA UDI
- Primary DI / UDI-DI
- 00817518020297 FDA UDI
- FDA Product Code
- CAE FDA UDI
- GMDN Term
- Anaesthesia face mask, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5110 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
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
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
Category: Anaesthesia face mask, reusable
Sharn Inc by Sharn Anesthesia — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anaesthesia face mask, reusable.
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- Anesthesia Face Mask Pre-Filled Inflatable Single Use Large Adult Size 5 — FLEXICARE MEDICAL LIMITED · Class I
- REPL SMALL NASAL HOOD — Parker Hannifin Corp. · Class I
- AincA® — Anesthesia Associates, Inc. · Class I
- REPL MEDIUM NASAL HOOD — Parker Hannifin Corp. · 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
- Sharn Anesthesia
Sources (1)
- FDA UDI 6be27350-1a96-4b8a-ae1d-ec96429c6d43 35 fields · synced May 30, 2026