Kool Kit® Neonate
Catalogue number 950, listed by Gentherm Medical, LLC, United States, under System, Thermal Regulating. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
1catalogue number
22recalls on this code
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (1), Anhui (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
| Copious Intl., Inc. | Heyuan, Guangdong Province | Contract manufacturer | 11 | |
| Jiangyin Puremed | Jiangyin | Jiangsu | Contract manufacturer | 7 |
| Betacera Inc. | Suzhou | Jiangsu | Contract manufacturer | 3 |
| Shanghai Xodus Medical Company Limited | Shanghai | Shanghai | Specification developer | 25 |
| Hangzhou Tappa Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 3 |
| Jiangmen Dacheng Medical Equipment Co., Ltd. | Jiangmen | Guangdong | Contract manufacturer | 1 |
Record
| Listed by | Gentherm Medical, LLC, United States |
|---|---|
| FDA product code | DWJ |
| Device type | System, Thermal Regulating |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5900 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Record published | 2017-08-30 |
| Record revised | 2023-12-18 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature -40 to 150 °F; Storage environment temperature -40 to 65.6 °C; Storage environment humidity 20 to 95 % RH; Handling environment temperature 59 to 86 °F; Handling environment temperature 15 to 30 °C; Handling environment humidity 20 to 95 % RH |
| Sizes | Depth 1.63 in; width 11 in; length 14.25 in; weight 0.15 lb |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 950 | Depth 1.63 in | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mistral-Air | The Surgical Company International B.V. | 114 |
| Bair Hugger™ | 3M Company | 99 |
| IOB | Jiangmen Dacheng Medical Equipment Co., Ltd. | 68 |
| IOB | Iob Medical, Inc. | 61 |
| 3M™ Bair Hugger™ | 3M Company | 61 |
| Cocoon | Care Essentials PTY Ltd | 59 |
| Soft Air | Adroit Medical Systems, Inc. | 56 |
| Level 1 | ICU Medical, Inc | 49 |
| System, Thermal Regulating | Hangzhou Tappa Medical Technology Co., Ltd. | 47 |
| PremierPro | Prestige Ameritech | 39 |
| Bair Paws™ | 3M Company | 30 |
| SourceMark | Sourcemark, LLC. | 25 |
Showing 12 of 166. All products under System, Thermal Regulating
Recalls
11 of these are 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 |
|---|---|---|---|---|---|
| 2026-07-13 | Class II | Device Design | Overheating occurring on 115V CPU boards for the Blanketrol III Model 233, Innercool CoolBlue Model STx, and Blanketrol II Model 222S products may cause the device to shut down. | 182 units | |
| 2026-07-13 | Class II | Device Design | Overheating occurring on 115V CPU boards for the Blanketrol III Model 233, Innercool CoolBlue Model STx, and Blanketrol II Model 222S products may cause the device to shut down. | 46 units | |
| 2026-07-13 | Class II | Device Design | Overheating occurring on 115V CPU boards for the Blanketrol III Model 233, Innercool CoolBlue Model STx, and Blanketrol II Model 222S products may cause the device to shut down, | 9714 units | |
| 2019-07-02 | Class II | Labeling False and Misleading | Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes | 3932 | 2020-06-22 |
| 2019-07-02 | Class II | Labeling False and Misleading | Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes | 5291 | 2020-06-22 |
| 2019-07-02 | Class II | Labeling False and Misleading | Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes | 3726 | 2020-06-22 |
| 2019-06-20 | Class II | Labeling False and Misleading | The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage. | 674 | 2020-06-09 |
| 2019-06-20 | Class II | Labeling False and Misleading | The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage. | 1063 | 2020-06-09 |
| 2014-01-08 | Class II | Mixed-up of materials/components | The incorrect voltage component was placed into the device during manufacturing. This may make the device unable to maintain patient temperature during cooling mode. The device will continue to indicate that the unit is cooling because the | 7 units | 2014-06-06 |
| 2013-09-03 | Class II | Labeling Change Control | During a label review it was discovered that both the Blanketrol III Operations (57201-N) & Operations & Technical (56201-Q) manuals had verbiage added back into the manual during ECN M111-4260 (released 12/29/2011) which was previously rem | 115V – 396 units; 230V – 385 units | 2014-08-22 |
| 2013-05-15 | Class II | Software Manufacturing/Software Deployment | During a customer inquiry regarding a beta version of the Bill Data Export Software, Model USB-127, it was discovered that the wrong software version was released to a customer. | 12 Units | 2014-05-13 |
| 2012-02-03 | Not classified | Device Design | Design error. The probe jack contacts (terminals on certain of the firm’s ECMO Heater devices are located too close to the solid state relay contacts (terminals) which can lead to the terminals coming into contact with one another. If this | 298 units (115V=295 and 230V/240V=3) | 2013-02-26 |
| 2011-10-27 | Not classified | Software design | The suspect hyper-hypothermia device systems sold to physicians for research and/or the treatment of AIDS or Cancer patients, were not appropriately cleared by the FDA prior to distribution. | 16 of these devices were distributed in the U.S., and two (2 | 2013-02-26 |
| 2011-10-27 | Not classified | Software design | The suspect hyper-hypothermia device systems sold to physicians for research and/or the treatment of AIDS and Cancer patients, were not appropriately cleared by the FDA prior to distribution. | A total of 20 devices were distributed in the U.S. & 3 units | 2013-02-26 |
| 2011-07-20 | Not classified | Labeling design | Cincinnati Sub-Zero is conducting a field correction due to changes that have been made to the WarmAir Model 135 devices Operation and Technical Manuals in order to comply with FDA device labeling regulations. | 6561 units were distributed. | 2013-07-05 |
| 2011-06-01 | Not classified | Device Design | Due to its design the circuit breaker on the device could trip causing it to shut down and not provide heated air to the blanket. | 5474 units | 2013-08-02 |
| 2011-05-19 | Not classified | Nonconforming Material/Component | A component defect. The recalling firm determined that one of the connectors attached to the firm’s WarmAir 134 device’s Printed Circuit Board (PCB) can overheat. Should this event occur, the excess heat build up within the device may res | 463 units were distributed | 2013-02-26 |
| 2011-05-02 | Not classified | Device Design | The probe jack contacts (terminals) on certain of the firm’s ECMO Heater devices are located too close to the solid state relay contacts (terminals) which can lead to the terminals coming into contact with each other. If this situation occ | 116 units | 2013-03-07 |
| 2011-05-02 | Not classified | Device Design | The probe jack contacts (terminals) on certain of the firm’s ECMO Heater devices are located too close to the solid state relay contacts (terminals) which can lead to the terminals coming into contact with each other. If this situation occ | 212 units – U. S. distribution & 44 units foreign distributi | 2013-03-07 |
| 2010-10-18 | Not classified | Other | The firm initiated this recall due to changes that have been made to the Blanketrol III Model 233 device’s Operation and Operation/Technical Service Manuals, in order to stay in compliance with labeling regulations. | 763 – 115V Blanketrol III Model 233; & 133 – 115V CoolBlue M | 2013-03-08 |
| 2009-11-14 | Not classified | Other | Product is labeled as “Sterile”. It was observed that incomplete seals were created in the packaging materials during production. When the seal is compromised, the sterility of the product inside the package cannot be assured. | 1,095 Blankets | 2012-01-25 |
| 2009-02-16 | Not classified | Process control | The blower on the WarmAir 135 Warming Unit may overheat. Resistance in a connector between circuit board and wiring harness results in excessive heat that may melt connector or deform the outer casing of the blower unit. | 2,674 units | 2012-09-19 |
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.