Mistral-Air
Mistral-Air is a forced-air patient warming family that pairs an electrically powered warming unit with a warming blanket or other patient-contact configuration. It raises and maintains…
Mistral-Air is a forced-air patient warming family that pairs an electrically powered warming unit with a warming blanket or other patient-contact configuration. It raises and maintains patient temperature by distributing warmed air at the body surface.
A fan and heating element send air through a flexible hose to the warming surface. Blanket configurations can lie over or beneath the patient, and a tube configuration can surround the patient.
Listed Item
Mistral-AIR Premium Suit, XL MA Premium Suit, XL, Silver/Blue, 1/BG, 10 BG/CS Nonwoven
Warming Surface Options
The blanket range includes adult, pediatric, neonatal and partial-body forms. These blankets use polypropylene and polyethylene and are intended for one patient; most are supplied nonsterile, with a sterile surgical-access option available.
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 | The Surgical Company International B.V., Netherlands |
|---|---|
| FDA product code | DWJ |
| Device type | System, Thermal Regulating |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5900 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K101705 |
| Record published | 2022-05-19 |
| Record revised | 2025-01-21 (version 6) |
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, serial number |
| Storage | Handling environment temperature -40 to 70 °C; Handling environment humidity 10 to 90 % RH; Handling environment atmospheric pressure 50 to 106 KiloPascal |
| Packaging | Box of 40, box of 10, case of 10, box of 2, box of 20, box of 100 |
| Distribution end date | 2025-01-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MA1710-PM | In distribution | |
| MA3450-PM | In distribution | |
| MA3350 | In distribution | |
| MA3455 | In distribution | |
| MA2230-PM | In distribution | |
| MA2280-PM | In distribution | |
| MA2400-PM | In distribution | |
| MA2400 | In distribution | |
| MA2290-PM | In distribution | |
| MA0510-PM | In distribution | |
| MA1640-PM | In distribution | |
| MA2260-PM | In distribution | |
| MA1200-PM | In distribution | |
| MA1720-PM | In distribution | |
| MA1740 | In distribution | |
| MA1630 | In distribution | |
| MA3475-PM | In distribution | |
| MA2285 | In distribution | |
| MA3365 | In distribution | |
| MA1710 | In distribution | |
| MA2286 | In distribution | |
| MA1710-PM | In distribution | |
| MA3330-PM | In distribution | |
| MA2290-PM | In distribution | |
| MA3450-PM | In distribution | |
| MA2240-PM | In distribution | |
| MA3340-PM | In distribution | |
| MA2455 | In distribution | |
| MA3360-PM | In distribution | |
| MA3320 | In distribution | |
| MA2250-PM | In distribution | |
| MA1100-PM | In distribution | |
| MA2265-PM | In distribution | |
| MA2450-PM | In distribution | |
| MA3320-PM | In distribution | |
| MA1200-QC-US | In distribution | |
| MA3330-PM | In distribution | |
| MA2240 | In distribution | |
| MA1740-PM | In distribution | |
| MA2220-PM | In distribution | |
| MA3340-PM | In distribution | |
| MA1200-US | In distribution | |
| MA2475-PM | In distribution | |
| MA2286-PM | In distribution | |
| MA2260 | In distribution | |
| MA1630-PM | In distribution | |
| MA1640 | In distribution | |
| MA3350-PM | In distribution | |
| MA2400-PM | In distribution | |
| MA2450-PM | In distribution | |
| MA1740-PM | In distribution | |
| MA2280 | In distribution | |
| MA3365-PM | In distribution | |
| MA3455-PM | In distribution | |
| MA2260-PM | In distribution | |
| MA3350-PM | In distribution | |
| MA0510-PM | In distribution | |
| MA2220-PM | In distribution | |
| MA2240-PM | In distribution | |
| MA2265 | In distribution | |
| MA3330 | In distribution | |
| MA1730-PM | In distribution | |
| MA2455-PM | In distribution | |
| MA2475 | In distribution | |
| MA1620-PM | In distribution | |
| MA3475 | In distribution | |
| MA2286-PM | In distribution | |
| MA3320-PM | In distribution | |
| MA1200-PM | In distribution | |
| MA1620 | In distribution | |
| MA2285-PM | In distribution | |
| MA3400-PM | In distribution | |
| MA2285-PM | In distribution | |
| MA3360-PM | In distribution | |
| MA3400-PM | In distribution | |
| MA1610-PM | In distribution | |
| MA3475-PM | In distribution | |
| MA3340 | In distribution | |
| MA2450 | In distribution | |
| MA3450 | In distribution | |
| MA2270-PM | In distribution | |
| MA3365-PM | In distribution | |
| MA0510 | In distribution | |
| MA1720 | In distribution | |
| MA2250 | In distribution | |
| MA2270 | In distribution | |
| MA5250-PM | In distribution | |
| MA3400 | In distribution | |
| MA3360 | In distribution | |
| MA1730 | In distribution | |
| MA02010 | In distribution | |
| MA2290 | In distribution | |
| MA5200-PM | In distribution | |
| MA2265-PM | In distribution | |
| MA2230-PM | In distribution | |
| MA5200 | In distribution | |
| MA2475-PM | In distribution | |
| MA1720-PM | In distribution | |
| MA2250-PM | In distribution | |
| MA2270-PM | In distribution | |
| MA2220 | In distribution | |
| MA2280-PM | In distribution | |
| MA1610 | In distribution | |
| MA1100-PM | In distribution | |
| MA2230 | In distribution | |
| MA0360-PM | Withdrawn | |
| MA0365-PM | Withdrawn | |
| MA0330-PM | Withdrawn | |
| MA0320-PM | Withdrawn | |
| MA0350-PM | Withdrawn | |
| MA02010-PM | Withdrawn | |
| MA0450-PM | Withdrawn | |
| MA0400-PM | Withdrawn | |
| MA0340-PM | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Kozee | Sourcemark, LLC. | 24 |
Showing 12 of 166. All products under System, Thermal Regulating
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K101705 | 2010-07-02 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Stryker GmbH | 510(k) number | 2017-07-21 | Class II | Component design/selection | It was identified that the Mistral-Air Premium blankets may be capable of conducting electricity during a defibrillation or cardioversion therapy at higher energy levels (70 Joules or more) when the blanket is applied with the reflective si | 11160 | 2018-03-22 |
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.