FDA UDI
In Commercial Distribution
🇺🇸 United States
Medical Warming Systems
DI: 00614801000079
·
Model: AC/DC Adaptor Cable
·
R.G. ENTERPRISES (U.S.A.), INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Medical Warming Systems
- Primary DI
- 00614801000079
- Version / Model
- AC/DC Adaptor Cable
- Catalog Number
- 82014
- Company Name
- R.G. ENTERPRISES (U.S.A.), INC.
- Labeler DUNS
- 928998905
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-09
- Public Version
- 1
- Public Version Date
- 2025-07-17
- Public Version Status
- New
- Public Device Record Key
- 747246c3-65eb-4077-91a4-a8927f15b84b
Device Description
Cable for plugging into an outlet for thermal regulating systems to prevent/treat hypothermia in pre clinical settings or treatment on site. Intended for use at rescue scene, during patient transport by air or ground to medical facility. Selectable temperature ranging from 98.6F top 104F via control unit with visual and acoustic alarm systems to indicate when temperature is reached.
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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| DWJ | System, Thermal Regulating | Cardiovascular | 870.5900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36545 | Basic power supply, reusable | A device designed to receive alternating-current energy (AC-power) from a mains electricity power line and deliver one or more regulated direct-current outputs to supply devices with electrical energy. It typically consists of a step-up or step-down transformer, a rectifier, a filter, and an electronic regulator that keeps the voltage, current, or power output stable over a broad range of loads and input voltages. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00614801000079 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K093694 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -22 – 158 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 95 Percent (%) Relative Humidity