FDA UDI
In Commercial Distribution
🇺🇸 United States
Resuscitaire Birthing Room Warmer (WBR82)
DI: 04049098000185
·
Model: MU20512
·
DRAEGER MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Resuscitaire Birthing Room Warmer (WBR82)
- Primary DI
- 04049098000185
- Version / Model
- MU20512
- Company Name
- DRAEGER MEDICAL SYSTEMS, INC.
- Labeler DUNS
- 788289952
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-24
- Public Version
- 3
- Public Version Date
- 2024-09-19
- Public Version Status
- Update
- Public Device Record Key
- d2023571-a3d0-4848-81e2-06cbdc543450
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 Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMT | Warmer, Infant Radiant | General Hospital | 880.5130 | 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 in some cases humidity levels, mainly for premature infants and other newborns who cannot effectively regulate their body temperature; it is typically on wheels and is designed for transporting infants either outside or within the healthcare facility. It typically consists of a clear removable/openable plastic hood with a mattress and operates using mains electricity (AC-powered) when not in use for transportation; some types may be supplied with an equipment rack. During transport, it is connected to an ambulance electrical outlet or is battery-powered. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04049098000185 | GS1 |
Customer Contacts
- Phone
- +18004372437
- [email protected]