Identity
- Trade Name
- Life Support Products FDA UDI
- Generic Name
- Transport electric ventilator FDA UDI
- Device Name
- Mass Casualty Ventilator, w/B, Pneumatic and Electric FDA UDI
- Model / Reference
- MCV200-B FDA UDI
- Description
- Mass Casualty Ventilator, w/B, Pneumatic and Electric FDA UDI
Identifiers
- Catalog Number
- MCV200-B FDA UDI
- Primary DI / UDI-DI
- 00026072001530 FDA UDI
- 510(k) Number
- K083385 FDA UDI
- FDA Product Code
- BTL FDA UDI
- GMDN Term
- Transport electric ventilator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5925 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
No
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
Category: Transport electric ventilator
Life Support Products by Allied Medical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Transport electric ventilator.
- PATIENT CIRCUITS — Zoll Medical Corporation · Class II
- Bio-Med Devices, Inc. — Bio-Med Devices, Inc. · Class II
- VENT — Zoll Medical Corporation · Class II
- PATIENT CIRCUITS — Zoll Medical Corporation · Class II
- Z Vent — Zoll Medical Corporation · Class II
- Bio-Med Devices, Inc. — Bio-Med Devices, Inc. · Class II
- Bio-Med Devices, Inc. — Bio-Med Devices, Inc. · Class II
- VENTILATOR — Zoll Medical Corporation · Class II
Cleared under the same submission
K083385 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
- Allied Medical LLC
Sources (1)
- FDA UDI 70975c53-e7e8-4098-acac-861bd4bdffb9 35 fields · synced May 31, 2026