Identity
- Trade Name
- NxtGen Infant Transport Incubator FDA UDI
- Generic Name
- Transport infant incubator FDA UDI
- Device Name
- Infant Transport Incubator Suction Device FDA UDI
- Model / Reference
- NxtGen FDA UDI
- Description
- Infant Transport Incubator Suction Device FDA UDI
Identifiers
- Catalog Number
- 738-2134 FDA UDI
- Primary DI / UDI-DI
- 00850018561013 FDA UDI
- 510(k) Number
- K220742 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
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
Category: Transport infant incubator
NxtGen Infant Transport Incubator by International Biomedical, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K220742 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
- International Biomedical, Ltd.
Sources (1)
- FDA UDI 13b1eac7-e23c-4ece-9127-bf8086d36b4e 35 fields · synced May 30, 2026