Identity
- Trade Name
- Venti.Plus FDA UDI
- Generic Name
- Anaesthesia face mask, reusable FDA UDI
- Model / Reference
- H100-M FDA UDI
Identifiers
- Catalog Number
- Hyperinflation System 1.0L with Mask FDA UDI
- Primary DI / UDI-DI
- 04710810100505 FDA UDI
- 510(k) Number
- K092687 FDA UDI
- FDA Product Code
- NHK FDA UDI
- GMDN Term
- Anaesthesia face mask, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5905 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
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
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
Venti.Plus by Galemed Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anaesthesia face mask, reusable.
- Nasal Hood For Anesthesia Reusable Large — FLEXICARE MEDICAL LIMITED · Class I
- AincA® — Anesthesia Associates, Inc. · Class I
- Anesthesia Face Mask Silicone Reusable Adult Size 4 — FLEXICARE MEDICAL LIMITED · Class I
- AincA® — Anesthesia Associates, Inc. · Class I
- 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
Cleared under the same submission
K092687 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Galemed Corp.
Sources (1)
- FDA UDI 99a63c3a-f484-41f6-a485-5308eb5e7e03 34 fields · synced May 30, 2026