DeRoyal
HYDRO-TEMP® Neonatal Temperature Skin Sensor
3manufacturers in China registered for this device type
37catalogue numbers in this listing
3510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Amphenol (Changzhou) Connector Systems Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 4 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | FMT |
| Device type | Warmer, Infant Radiant |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5130 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-12 |
| Record revised | 2021-08-11 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 50, case of 200, box of 100, box of 50, case of 100, box of 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HNICU-22 | In distribution | |
| VHNICU-25 | In distribution | |
| HNICU-33 | In distribution | |
| FNICU-35 | In distribution | |
| HNICU-35 | In distribution | |
| HNICU-38 | In distribution | |
| 81-011700 | In distribution | |
| 81-011400 | In distribution | |
| HNICU-26 | In distribution | |
| M1024222VY | In distribution | |
| HNICU-04 | In distribution | |
| HNICU-29 | In distribution | |
| HNICU-37 | In distribution | |
| HNICU-01 | In distribution | |
| HNICU-36 | In distribution | |
| HNICU-31 | In distribution | |
| FNICU-36 | In distribution | |
| HNICU-39 | In distribution | |
| 81-010700 | In distribution | |
| VHNICU-37 | In distribution | |
| HNICU-32 | In distribution | |
| HNICU-30 | In distribution | |
| FNICU-37 | In distribution | |
| HNICU-34 | In distribution | |
| HNICU-05 | In distribution | |
| HNICU-05B | In distribution | |
| 81-010400EU | In distribution | |
| FNICU-26 | In distribution | |
| HNICU-25 | In distribution | |
| M00328-HPG | In distribution | |
| VHNICU-35 | In distribution | |
| HNICU-02 | In distribution | |
| 81-010400 | In distribution | |
| HNICU-03 | In distribution | |
| M00328-P | In distribution | |
| HNICU-00 | In distribution | |
| FNICU-25 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fisher & Paykel Healthcare | Fisher & Paykel Healthcare, Ltd. | 9 |
| AirLife™ | AirLife Finland Oy | 8 |
| Tarry Probes | Tarry Medical Products, Inc. | 5 |
| Argyle | Cardinal Health | 5 |
| Panda | Datex-Ohmeda, Inc. | 4 |
| AccuTemp Probe | Kentec Medical, LLC | 3 |
| Ameritus | Kentec Medical, LLC | 3 |
| AirLife | Carefusion Finland 320 Oy | 3 |
| F&P Neopuff | Fisher & Paykel Healthcare, Ltd. | 2 |
| Sunflower Warmer, Stand AC120V | Atom Medical Corporation | 2 |
| Heating Element 540W-104V | RPI | 2 |
| Sunflower Warmer, Wall Mount AC120V | Atom Medical Corporation | 2 |
Showing 12 of 39. All products under Warmer, Infant Radiant
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200319 | 2020-04-02 |
| K191425 | 2020-01-21 |
| K925006 | 1994-01-31 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-10-14 | Class II | Process control | DeRoyal manufactured four lots of HNICU-32, Hydro-Temp(R) Neonatal Temperature Skin Sensor incorrectly. The pins contained in the probe were soldered incorrectly. When probe is connected to the proper port, this defect results in the inabil | 16 cases of 50 units (800 eaches) | 2017-07-01 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.