FDA UDI
Not in Commercial Distribution
🇺🇸 United States
LMT nomag® IC 3.0
DI: 04260486610032
·
Model: 0100020
·
LMT Medical Systems GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LMT nomag® IC 3.0
- Primary DI
- 04260486610032
- Version / Model
- 0100020
- Company Name
- LMT Medical Systems GmbH
- Labeler DUNS
- 312688686
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-14
- Public Version
- 4
- Public Version Date
- 2023-11-06
- Public Version Status
- Update
- Public Device Record Key
- 26f68e93-1449-468c-8f50-0ccf3dbec9e7
- Distribution End Date
- 2018-08-31
Device Description
No description.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- 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 | 04260486610032 | GS1 |
Customer Contacts
- Phone
- +49451580980
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K062052 | 000 |