Identity
- Trade Name
- Evita VPack invasive FDA UDI
- Generic Name
- Heat/moisture exchanger/microbial medical gas filter FDA UDI
- Model / Reference
- MP01657 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048675421146 FDA UDI
- FDA Product Code
- CAI FDA UDI
- GMDN Term
- Heat/moisture exchanger/microbial medical gas filter FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5240 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Ventilator breathing circuit, single-useStraight/elbow breathing circuit connector, single-useHeat/moisture exchanger/microbial medical gas filterNeonatal/adult intensive-care ventilator
Evita VPack invasive by Drägerwerk AG & Co. KGaA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Neonatal/adult intensive-care ventilator.
- Aeroneb Module control cable — Maquet Critical Care AB · Class II
- VMAX — VYAIRE MEDICAL, INC. · Class II
- Puritan Bennett — Covidien LP · Class II
- Neumovent — Tecme Corporation · Class II
- Puritan Bennett — Covidien LP · Class II
- AVEA II — VYAIRE MEDICAL, INC. · Class II
- AVEA™ — VYAIRE MEDICAL, INC. · Class II
- Puritan Bennett — Covidien LP · 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Drägerwerk AG & Co. KGaA
Sources (1)
- FDA UDI 98ff90d8-1ad8-43a8-857e-45b89ba85669 33 fields · synced May 30, 2026