DeRoyal
- Primary DI
- 30749756166318
- Brand
- DeRoyal
- Company
- DEROYAL INDUSTRIES, INC.
- Model
- HNICU-02
- Device description
- HYDRO-TEMP® Cover without Foam
- Published
- 2016-09-12
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| FMT | WARMER, INFANT RADIANT |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| FMT | Warmer, Infant Radiant | General Hospital | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 30749756166318 | Package | GS1 | 100 | In Commercial Distribution |
| 50749756166312 | Package | GS1 | 200 | In Commercial Distribution |
| 00749756166317 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 30749756166318 | 30749756166318 | | |
| 50749756166312 | 50749756166312 | | |
| 00749756166317 | 00749756166317 | 749756166317 | 0749756166317 |
GMDN Terms
| Term | Definition |
|---|
| General-purpose patient temperature probe, single-use | A temperature sensing device intended to be placed into a body orifice or on the body surface, and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. This is a single-use device. |
Regulatory Flags
- DUNS number
- 096372255
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 20889483587888 | AirLife™ | AirLife Finland Oy | FMT | 2025-03-26 |
| 20889483587901 | AirLife™ | AirLife Finland Oy | FMT | 2025-03-26 |
| 10889483587959 | AirLife™ | AirLife Finland Oy | FMT | 2025-03-26 |
| 00865648000313 | NuBorne Infant Warmer | INTERNATIONAL BIOMEDICAL, LTD. | FMT | 2023-06-20 |
| 04049098099042 | Babyroo TN300 Infant Radiant Warmer | DRAEGER MEDICAL SYSTEMS, INC. | FMT | 2023-06-08 |
| 50749756379200 | DeRoyal | DEROYAL INDUSTRIES, INC. | FMT | 2023-02-06 |
| 30749756772359 | DeRoyal | DEROYAL INDUSTRIES, INC. | FMT | 2021-07-12 |
| 50749756927555 | DeRoyal | DEROYAL INDUSTRIES, INC. | FMT | 2021-05-07 |
| 50749756927562 | DeRoyal | DEROYAL INDUSTRIES, INC. | FMT | 2021-05-07 |
| 50749756927579 | DeRoyal | DEROYAL INDUSTRIES, INC. | FMT | 2021-05-07 |
| 50749756983988 | DeRoyal | DEROYAL INDUSTRIES, INC. | FMT | 2021-05-07 |
| 50749756995561 | DeRoyal | DEROYAL INDUSTRIES, INC. | FMT | 2021-05-07 |
| 50749756372300 | DeRoyal | DEROYAL INDUSTRIES, INC. | FMT | 2021-03-22 |
| 10190752181236 | Airlife™ | VYAIRE MEDICAL, INC. | FMT | 2021-03-09 |
| 20190752181196 | Airlife™ | VYAIRE MEDICAL, INC. | FMT | 2021-03-05 |
| 50190752181203 | Airlife | VYAIRE MEDICAL, INC. | FMT | 2021-02-26 |
| 20190752106113 | AirLife™ | Vyaire Medical Oy | FMT | 2021-01-28 |
| 50190752106121 | AirLife™ | Vyaire Medical Oy | FMT | 2021-01-28 |
| 00840682152709 | Panda | Datex-Ohmeda, Inc. | FMT | 2020-06-11 |
| 10854758006176 | Access Medical Probes | TARRY MEDICAL PRODUCTS, INC. | FMT | 2018-09-13 |
| 10885403257353 | AirLife | Carefusion Finland 320 Oy | FMT | 2017-10-31 |
| 04942962615761 | Sunflower Warmer, Stand AC120V | ATOM MEDICAL CORPORATION | FMT | 2016-12-27 |
| 04942962615778 | Sunflower Warmer, Wall Mount AC120V | ATOM MEDICAL CORPORATION | FMT | 2016-12-27 |
| 00841034102762 | HEATING ELEMENT 560W-120V | RPI | FMT | 2016-12-09 |
| 00841034102779 | HEATING ELEMENT 600W-120V | RPI | FMT | 2016-12-09 |
| 00841034102793 | HEATING ELEMENT 600W-240V | RPI | FMT | 2016-12-09 |
| 00841034102809 | HEATING ELEMENT 741W-120V | RPI | FMT | 2016-12-09 |
| 00841034102816 | HEATING ELEMENT 560W-220V | RPI | FMT | 2016-12-09 |
| 00841034102823 | HEATING ELEMENT 350W-120V | RPI | FMT | 2016-12-09 |
| 00841034102830 | HEATING ELEMENT | RPI | FMT | 2016-12-09 |
deroyal.com