Identity
- Trade Name
- Ventlab FDA UDI
- Generic Name
- Pulmonary resuscitator, manual, single-use FDA UDI
- Device Name
- PEDIATRIC BAG, INTERSURG #2 MASK W/INFLATABLE BAG RESERVOIR, POP-OFF & MANO FDA UDI
- Model / Reference
- AFI2142MB FDA UDI
- Description
- PEDIATRIC BAG, INTERSURG #2 MASK W/INFLATABLE BAG RESERVOIR, POP-OFF & MANO FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10889483084366 FDA UDI
- FDA Product Code
- BTM FDA UDI
- GMDN Term
- Pulmonary resuscitator, manual, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5915 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
Dimensions & Sizes
- Size
- Total Volume — 1000 Milliliter FDA UDI
Category: Pulmonary resuscitator, manual, single-use
Ventlab by Ventlab Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Pulmonary resuscitator, manual, single-use.
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- AirLife™ — Airlife, Inc. · Class II
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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 92858455-3d41-4045-8421-ebc3cd113c4e 36 fields · synced May 31, 2026