Identity
- Trade Name
- V-Care FDA UDI
- Generic Name
- Pulmonary resuscitator, manual, single-use FDA UDI
- Device Name
- V-Care Infant Resuscitator with Collapsible Accumulator, Integrated Manometer, 40cm H2O Pop-off, B/V Filter, PEEP Valve and Mask FDA UDI
- Model / Reference
- VN3100MXP-F FDA UDI
- Description
- V-Care Infant Resuscitator with Collapsible Accumulator, Integrated Manometer, 40cm H2O Pop-off, B/V Filter, PEEP Valve and Mask FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10889483230664 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 — 300 Milliliter FDA UDI
Category: Pulmonary resuscitator, manual, single-use
V-Care 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 b94e2ecd-93f8-42ca-a382-5c32b8bf82bd 36 fields · synced May 29, 2026