FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Babytherm 8010 System
DI: 04048675017097
·
Model: 2M22380
·
Drägerwerk AG & Co. KGaA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Babytherm 8010 System
- Primary DI
- 04048675017097
- Version / Model
- 2M22380
- Company Name
- Drägerwerk AG & Co. KGaA
- Labeler DUNS
- 315578914
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-24
- Public Version
- 4
- Public Version Date
- 2024-08-23
- Public Version Status
- Update
- Public Device Record Key
- 542bea9f-c7ff-45ca-89bd-ed4ad127aa07
- Distribution End Date
- 2024-08-22
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
- No
- 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 |
|---|---|---|---|---|
| 17433 | Infant warmer | A mains electricity (AC-powered) mobile device that contains an infrared (IR) heating element(s) designed to emit controlled, evenly distributed overhead heat to the body of a newborn/infant patient requiring supplemental heat. This device is equipped with wheels so that it can easily be moved to different areas of a room, ward, or department. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 04048675246558 | GS1 | ||||
| Primary | 04048675017097 | GS1 |
Customer Contacts
- Phone
- +494518820
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K971198 | 000 |