Identity
- Trade Name
- Bio-Med Devices, Inc. FDA UDI
- Generic Name
- Portable pneumatic ventilator FDA UDI
- Device Name
- Infant Ventilator, pneumatic, MR-conditional FDA UDI
- Model / Reference
- MVP-10 FDA UDI
- Description
- Infant Ventilator, pneumatic, MR-conditional FDA UDI
Identifiers
- Catalog Number
- 2010M FDA UDI
- Primary DI / UDI-DI
- 00813841020904 FDA UDI
- FDA Product Code
- CBK FDA UDI
- GMDN Term
- Portable pneumatic ventilator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5895 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Portable pneumatic ventilator
Bio-Med Devices, Inc. by Bio-Med Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Portable pneumatic ventilator.
- pNeuton — AIRON CORPORATION · Class II
- pNeuton — AIRON CORPORATION · Class II
- Emergent Respiratory — MDL SOLUTIONS INCORPORATED · Class II
- Percussionaire — Percussionaire Corporation · Class II
- PAHI VersalVent — Pan-America Hyperbarics, Inc. · Class II
- CAREvent MRI — O-Two Medical Technologies Inc · Class II
- Life2000 — Welch Allyn, Inc. · Class II
- Penlon — Penlon , Ltd. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bio-Med Devices, Inc.
Sources (1)
- FDA UDI 55309212-48db-4bdd-a0f6-aaf888547dfa 35 fields · synced Jun 9, 2026