Bair Hugger™
3M™ Bair Hugger™ Patient Adjustable Warming Unit, 120V-ENG-E, Refurbished, 1 each, 89500
8manufacturers in China registered for this device type
99catalogue 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 | 3M Company, United States |
|---|---|
| FDA product code | DWJ |
| Device type | System, Thermal Regulating |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5900 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-24 |
| Record revised | 2026-03-16 (version 7) |
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 |
| Distribution end date | 2024-08-19 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 81202 | 20 | In distribution | |
| 53000 | 10 | In distribution | |
| 11101 | 10 | In distribution | |
| 58501 | 10 | In distribution | |
| 54000 | 10 | In distribution | |
| 64500 | 5 | In distribution | |
| 81001 | 30 | In distribution | |
| 52500 | 10 | In distribution | |
| 30500 | 10 | In distribution | |
| 42568 | 10 | In distribution | |
| 58501 | 10 | In distribution | |
| 84101 | 20 | In distribution | |
| 63000 | 5 | In distribution | |
| 83103 | 20 | In distribution | |
| 83003 | 30 | In distribution | |
| 53700 | 10 | In distribution | |
| 54500 | 10 | In distribution | |
| 61000 | 10 | In distribution | |
| 83002 | 30 | In distribution | |
| 52301 | 10 | In distribution | |
| 55000 | 10 | In distribution | |
| 84203 | 20 | In distribution | |
| 81103 | 20 | In distribution | |
| 89500 | In distribution | ||
| 84002 | 30 | In distribution | |
| 81002 | 30 | In distribution | |
| 84102 | 20 | In distribution | |
| 55501 | 10 | In distribution | |
| 40068 | 10 | In distribution | |
| 56000 | 10 | In distribution | |
| 30000 | 10 | In distribution | |
| 30500 | 10 | In distribution | |
| 31500 | 10 | In distribution | |
| 55501 | 10 | In distribution | |
| 81201 | 20 | In distribution | |
| 22110 | In distribution | ||
| 31000 | 10 | In distribution | |
| 52301 | 10 | In distribution | |
| 22110 | In distribution | ||
| 77500 | In distribution | ||
| 77500 | In distribution | ||
| 81101 | 20 | In distribution | |
| 30000 | 10 | In distribution | |
| 84103 | 20 | In distribution | |
| 31000 | 10 | In distribution | |
| 11000 | 10 | In distribution | |
| 83101 | 20 | In distribution | |
| 90055 | In distribution | ||
| 57501 | 5 | In distribution | |
| 62200 | 10 | In distribution | |
| 44068 | 10 | In distribution | |
| 57501 | 5 | In distribution | |
| 57000 | 10 | In distribution | |
| 81501 | 20 | In distribution | |
| 84001 | 30 | In distribution | |
| 63500 | 10 | In distribution | |
| 52200 | 10 | In distribution | |
| 83202 | 20 | In distribution | |
| 84003 | 30 | In distribution | |
| 83102 | 20 | In distribution | |
| 63000 | 5 | In distribution | |
| 54200 | 10 | In distribution | |
| 64500 | 5 | In distribution | |
| 81102 | 20 | In distribution | |
| 63700 | 5 | In distribution | |
| 42568 | 10 | In distribution | |
| 55000 | 10 | In distribution | |
| 11101 | 10 | In distribution | |
| 53700 | 10 | In distribution | |
| 83201 | 20 | In distribution | |
| 87500 | In distribution | ||
| 81203 | 20 | In distribution | |
| 54500 | 10 | In distribution | |
| 77533 | In distribution | ||
| 61000 | 10 | In distribution | |
| 31500 | 10 | In distribution | |
| 44068 | 10 | In distribution | |
| 42268 | 10 | In distribution | |
| 54200 | 10 | In distribution | |
| 77533 | In distribution | ||
| 11000 | 10 | In distribution | |
| 83001 | 30 | In distribution | |
| 52500 | 10 | In distribution | |
| 52200 | 10 | In distribution | |
| 63700 | 5 | In distribution | |
| 40068 | 10 | In distribution | |
| 84202 | 20 | In distribution | |
| 79500 | In distribution | ||
| 90055 | In distribution | ||
| 63500 | 5 | In distribution | |
| 53000 | 10 | In distribution | |
| 54000 | 10 | In distribution | |
| 42268 | 10 | In distribution | |
| 57000 | 10 | In distribution | |
| 83203 | 20 | In distribution | |
| 84201 | 20 | In distribution | |
| 56000 | 10 | Withdrawn | |
| 81003 | 30 | Withdrawn | |
| 79500 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mistral-Air | The Surgical Company International B.V. | 114 |
| 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 |
|---|---|
| K210605 | 2021-04-29 |
| K210603 | 2021-03-30 |
| K171373 | 2017-10-10 |
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 |
|---|---|---|---|---|---|
| 2018-01-23 | Class II | Finished device change control | Adesign change to 3M(TM) Bair Hugger(TM) Full Access Underbody Warming Blanket, Models 63500 and 63700, can make these blankets more susceptible to unintended occlusion of airflow resulting in limited or partial inflation during use. | 36 cases of 5 units | 2020-08-21 |
| 2018-01-23 | Class II | Finished device change control | Adesign change to 3M(TM) Bair Hugger(TM) Full Access Underbody Warming Blanket, Models 63500 and 63700, can make these blankets more susceptible to unintended occlusion of airflow resulting in limited or partial inflation during use. | 33108 cases of 5 units | 2020-08-21 |
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.