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Filter Element E(10 pcs/pkg) For V-808/V-850TR/V-80TR
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Filter Element E(10 pcs/pkg) For V-808/V-850TR/V-80TR FDA UDI
- Generic Name
- Transport infant incubator FDA UDI
- Model / Reference
- 60317 FDA UDI
Identifiers
- Catalog Number
- 60317 FDA UDI
- Primary DI / UDI-DI
- 04942962603171 FDA UDI
- FDA Product Code
- FPL FDA UDI
- GMDN Term
- Transport infant incubator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5410 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Transport infant incubator
Filter Element E(10 pcs/pkg) For V-808/V-850TR/V-80TR by Atom Medical Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Transport infant incubator.
- 185A+ Infant Incubator — INTERNATIONAL BIOMEDICAL, LTD. · Class II
- Resuscitaire Radiant Warmer (RW82, RW82 VHA) — Draeger Medical Systems, Inc. · Class II
- Breathing bag set with PEEP valve, disposable — Draeger Medical Systems, Inc. · Class II
- 185A+ Infant Incubator — INTERNATIONAL BIOMEDICAL, LTD. · Class II
- CosyCrib — INSPIRATION HEALTHCARE GROUP PLC · Class I
- Aviator Transport Incubator — INTERNATIONAL BIOMEDICAL, LTD. · Class II
- A750i Infant Incubator — INTERNATIONAL BIOMEDICAL, LTD. · Class II
- CosyCrib — INSPIRATION HEALTHCARE GROUP PLC · Class I
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
- Atom Medical Corp
Sources (1)
- FDA UDI b603f84d-6765-4c49-9254-d904461c0e02 34 fields · synced May 31, 2026