Argyle
Hydrogel Temperature Probe Cover,Duck & Bear Shaped, Small
3manufacturers in China registered for this device type
5catalogue numbers in this listing
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 | Cardinal Health, United States |
|---|---|
| FDA product code | FMT |
| Device type | Warmer, Infant Radiant |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5130 |
| Establishment | Contract manufacturer, Reprocessor, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K964401 |
| Record published | 2016-09-24 |
| Record revised | 2019-02-15 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep dry;AVOID DIRECT SUNLIGHT |
| Packaging | Case of 200, case of 800 |
| Sizes | Length 1.25 in; width 0.75 in |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 31424784 | 100 | In distribution | |
| 31424792 | 100 | In distribution | |
| MI30002 | Length 1.25 in | 80 | In distribution |
| 43101 | In distribution | ||
| 43102 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 37 |
| Fisher & Paykel Healthcare | Fisher & Paykel Healthcare, Ltd. | 9 |
| AirLife™ | AirLife Finland Oy | 8 |
| Tarry Probes | Tarry Medical Products, Inc. | 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
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.