Identity
- Trade Name
- Ventlab FDA UDI
- Generic Name
- Airway pressure monitor, non-powered FDA UDI
- Device Name
- 1/2 L Hyperinflation system w/ manometer, pop-off & size 2 blow mold mask FDA UDI
- Model / Reference
- 2002HZ FDA UDI
- Description
- 1/2 L Hyperinflation system w/ manometer, pop-off & size 2 blow mold mask FDA UDI
Identifiers
- Catalog Number
- 2002HZ FDA UDI
- Primary DI / UDI-DI
- 10889483165508 FDA UDI
- FDA Product Code
- NHK FDA UDI
- GMDN Term
- Airway pressure monitor, non-powered 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 0.5 Liter FDA UDI
Category: Airway pressure monitor, non-powered
Ventlab by Ventlab Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Ventlab Corp.
Sources (1)
- FDA UDI 385284df-0065-4a98-a27b-18e8699b4820 36 fields · synced Jun 1, 2026