FDA UDI
In Commercial Distribution
🇺🇸 United States
NxtGen Infant Transport Incubator
DI: 00850018561013
·
Model: NxtGen
·
INTERNATIONAL BIOMEDICAL, LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NxtGen Infant Transport Incubator
- Primary DI
- 00850018561013
- Version / Model
- NxtGen
- Catalog Number
- 738-2134
- Company Name
- INTERNATIONAL BIOMEDICAL, LTD.
- Labeler DUNS
- 073179368
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-27
- Public Version
- 2
- Public Version Date
- 2023-04-10
- Public Version Status
- Update
- Public Device Record Key
- 13b1eac7-e23c-4ece-9127-bf8086d36b4e
Device Description
Infant Transport Incubator Suction Device
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FPL | Incubator, Neonatal Transport | General Hospital | 880.5410 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35121 | Transport infant incubator | An electrically-powered unit designed to provide an enclosed controlled environment to maintain appropriate temperature and humidity levels mainly for premature infants and other newborns who cannot effectively regulate their body temperature; it is typically on wheels and also designed for transporting infants either outside or within the healthcare facility. It typically consists of a clear removable plastic hood with a mattress and operates using mains electricity (AC-powered) when not in use for transportation. During transport, it is connected to an ambulance electrical outlet or is battery-powered from a battery pack. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850018561013 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K220742 | 000 |