Cocoon
Cocoon Disposable Full Pre-Warming Gown Blanket XL with Kit
8manufacturers in China registered for this device type
59catalogue numbers in this listing
3510(k) clearances naming this product code
2recalls 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 | Care Essentials PTY Ltd, Australia |
|---|---|
| FDA product code | DWJ |
| Device type | System, Thermal Regulating |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5900 |
| Establishment | Contract manufacturer, Manufacturer |
| Record published | 2021-03-01 |
| Record revised | 2023-12-18 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| 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, serial number |
| Packaging | Carton of 10, carton of 30, carton of 100 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CWS 5000 | In distribution | |
| CLM 0127P | In distribution | |
| CLM 097K | In distribution | |
| CLM 0108 | In distribution | |
| CLM 0145S | In distribution | |
| CLM 0121 | In distribution | |
| CLM 0102 | In distribution | |
| CLM 0107 | In distribution | |
| CLM 0129 | In distribution | |
| CLM 0133 | In distribution | |
| CLM 0145R-K | In distribution | |
| CLM 0103 | In distribution | |
| CLM 0142 | In distribution | |
| CLM 0109 | In distribution | |
| CLM 0143 | In distribution | |
| CLM 098K | In distribution | |
| CLM 0120 | In distribution | |
| CLM 0147 | In distribution | |
| CLM 0141 | In distribution | |
| CLM 0145L-K | In distribution | |
| CLM 0112 | In distribution | |
| CLM 0202 | In distribution | |
| CLM 0101 | In distribution | |
| CLM 0137 | In distribution | |
| CLM 0107-TP | In distribution | |
| CLM 0122 | In distribution | |
| CLM 0132 | In distribution | |
| CLM 0115 | In distribution | |
| CLM 097 | In distribution | |
| CLM 0105-TP | In distribution | |
| CLM 099K | In distribution | |
| CLM 0145K | In distribution | |
| CLM 0116 | In distribution | |
| CLM 0145L | In distribution | |
| CLM 0125 | In distribution | |
| CLM 0131 | In distribution | |
| CWS 4000 | In distribution | |
| CLM 0138 | In distribution | |
| CLM 096 | In distribution | |
| CLM 0145S-K | In distribution | |
| CLM 0106 | In distribution | |
| CLM 0128 | In distribution | |
| CLM 098 | In distribution | |
| CLM 0130 | In distribution | |
| CLM 0113 | In distribution | |
| CLM 0124 | In distribution | |
| CLM 0105L | In distribution | |
| CLM 0145 | In distribution | |
| CLM 0126 | In distribution | |
| CLM 0117 | In distribution | |
| CLM 099 | In distribution | |
| CLM 0118 | In distribution | |
| CLM 0127 | In distribution | |
| CLM 143K | In distribution | |
| CLM 096K | In distribution | |
| CLM 0104 | In distribution | |
| CLM 0145R | In distribution | |
| CLM 0105 | In distribution | |
| CLM 095K | 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 |
| 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 |
| Kozee | Sourcemark, LLC. | 24 |
Showing 12 of 166. All products under System, Thermal Regulating
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K232502 | 2024-02-21 |
| K181671 | 2019-05-02 |
| K140635 | 2014-07-25 |
Recalls
2 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 |
|---|---|---|---|---|---|
| 2020-01-07 | Class II | Other | Potential for thermal damage near the power cord connector and Power Entry Module (PEM) due to improper connection of the power cord connector and PEM pins on the Cocoon Convective Warming System. | 689 | 2023-03-22 |
| 2020-01-07 | Class II | Other | Potential for thermal damage near the power cord connector and Power Entry Module (PEM) due to improper connection of the power cord connector and PEM pins on the Cocoon Convective Warming System. | 251 | 2023-03-22 |
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.