12 MedaFit
126 catalogue numbers from 12BK, listed by Sigvaris, Inc., United States, under Binder, Medical, Therapeutic. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
126catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo MPF Manufacturing Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 35 |
| Jiangsu Xinbei Electrical Appliances Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 6 |
Record
| Listed by | Sigvaris, Inc., United States |
|---|---|
| FDA product code | MDR |
| Device type | Binder, Medical, Therapeutic |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5160 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-01-30 |
| Record revised | 2024-12-11 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 12BK | Pressure,15-20 mmHg | In distribution |
| 12BK | Pressure,15-20 mmHg | In distribution |
| 12TH | Pressure,15-20 mmHg | In distribution |
| 12BK | Pressure,15-20 mmHg | In distribution |
| 12AR | Pressure,15-20 mmHg | In distribution |
| 12DG | Pressure,15-20 mmHg | In distribution |
| 12TH | Pressure,15-20 mmHg | In distribution |
| 12TM | Pressure,15-20 mmHg | In distribution |
| 12GL | Pressure,15-20 mmHg | In distribution |
| 12AR | Pressure,15-20 mmHg | In distribution |
| 12BK | Pressure,15-20 mmHg | In distribution |
| 12AR | Pressure,15-20 mmHg | In distribution |
| 12BK | Pressure,15-20 mmHg | In distribution |
| 12HD | Pressure,15-20 mmHg | In distribution |
| 12AR | Pressure,15-20 mmHg | In distribution |
| 12HD | Pressure,15-20 mmHg | In distribution |
| 12AR | Pressure,15-20 mmHg | In distribution |
| 12BK | Pressure,15-20 mmHg | In distribution |
| 12AR | Pressure,15-20 mmHg | In distribution |
| 12TM | Pressure,15-20 mmHg | In distribution |
| 12DG | Pressure,15-20 mmHg | In distribution |
| 12TM | Pressure,15-20 mmHg | In distribution |
| 12BK | Pressure,15-20 mmHg | In distribution |
| 12AR | Pressure,15-20 mmHg | In distribution |
| 12BK | Pressure,15-20 mmHg | In distribution |
| 12TM | Pressure,15-20 mmHg | In distribution |
| 12TM | Pressure,15-20 mmHg | In distribution |
| 12BK | Pressure,15-20 mmHg | In distribution |
| 12TH | Pressure,15-20 mmHg | In distribution |
| 12TH | Pressure,15-20 mmHg | In distribution |
| 12TH | Pressure,15-20 mmHg | In distribution |
| 12AR | Pressure,15-20 mmHg | In distribution |
| 12BK | Pressure,15-20 mmHg | In distribution |
| 12TH | Pressure,15-20 mmHg | In distribution |
| 12TH | Pressure,15-20 mmHg | In distribution |
| 12AR | Pressure,15-20 mmHg | In distribution |
| 12AR | Pressure,15-20 mmHg | In distribution |
| 12TM | Pressure,15-20 mmHg | In distribution |
| 12HD | Pressure,15-20 mmHg | In distribution |
| 12GL | Pressure,15-20 mmHg | In distribution |
| 12BK | Pressure,15-20 mmHg | In distribution |
| 12TM | Pressure,15-20 mmHg | In distribution |
| 12BK | Pressure,15-20 mmHg | In distribution |
| 12TM | Pressure,15-20 mmHg | In distribution |
| 12TH | Pressure,15-20 mmHg | In distribution |
| 12AR | Pressure,15-20 mmHg | In distribution |
| 12TM | Pressure,15-20 mmHg | In distribution |
| 12TH | Pressure,15-20 mmHg | In distribution |
| 12AR | Pressure,15-20 mmHg | In distribution |
| 12BK | Pressure,15-20 mmHg | In distribution |
| 12AR | Pressure,15-20 mmHg | In distribution |
| 12BK | Pressure,15-20 mmHg | In distribution |
| 12TH | Pressure,15-20 mmHg | In distribution |
| 12GL | Pressure,15-20 mmHg | In distribution |
| 12TM | Pressure,15-20 mmHg | In distribution |
| 12DG | Pressure,15-20 mmHg | In distribution |
| 12AR | Pressure,15-20 mmHg | In distribution |
| 12GL | Pressure,15-20 mmHg | In distribution |
| 12DG | Pressure,15-20 mmHg | In distribution |
| 12TH | Pressure,15-20 mmHg | In distribution |
| 12BK | Pressure,15-20 mmHg | In distribution |
| 12BK | Pressure,15-20 mmHg | In distribution |
| 12AR | Pressure,15-20 mmHg | In distribution |
| 12TH | Pressure,15-20 mmHg | In distribution |
| 12TH | Pressure,15-20 mmHg | In distribution |
| 12TM | Pressure,15-20 mmHg | In distribution |
| 12DG | Pressure,15-20 mmHg | In distribution |
| 12BK | Pressure,15-20 mmHg | In distribution |
| 12TH | Pressure,15-20 mmHg | In distribution |
| 12HD | Pressure,15-20 mmHg | In distribution |
| 12HD | Pressure,15-20 mmHg | In distribution |
| 12BK | Pressure,15-20 mmHg | In distribution |
| 12HD | Pressure,15-20 mmHg | In distribution |
| 12TM | Pressure,15-20 mmHg | In distribution |
| 12TH | Pressure,15-20 mmHg | In distribution |
| 12BK | Pressure,15-20 mmHg | In distribution |
| 12BK | Pressure,15-20 mmHg | In distribution |
| 12GL | Pressure,15-20 mmHg | In distribution |
| 12GL | Pressure,15-20 mmHg | In distribution |
| 12BK | Pressure,15-20 mmHg | In distribution |
| 12GL | Pressure,15-20 mmHg | In distribution |
| 12DG | Pressure,15-20 mmHg | In distribution |
| 12TM | Pressure,15-20 mmHg | In distribution |
| 12BK | Pressure,15-20 mmHg | In distribution |
| 12AR | Pressure,15-20 mmHg | In distribution |
| 12AR | Pressure,15-20 mmHg | In distribution |
| 12BK | Pressure,15-20 mmHg | In distribution |
| 12AR | Pressure,15-20 mmHg | In distribution |
| 12TH | Pressure,15-20 mmHg | In distribution |
| 12TH | Pressure,15-20 mmHg | In distribution |
| 12AR | Pressure,15-20 mmHg | In distribution |
| 12HD | Pressure,15-20 mmHg | In distribution |
| 12TM | Pressure,15-20 mmHg | In distribution |
| 12AR | Pressure,15-20 mmHg | In distribution |
| 12TH | Pressure,15-20 mmHg | In distribution |
| 12TH | Pressure,15-20 mmHg | In distribution |
| 12TH | Pressure,15-20 mmHg | In distribution |
| 12TH | Pressure,15-20 mmHg | In distribution |
| 12AR | Pressure,15-20 mmHg | In distribution |
| 12TM | Pressure,15-20 mmHg | In distribution |
| 12TM | Pressure,15-20 mmHg | In distribution |
| 12DG | Pressure,15-20 mmHg | In distribution |
| 12AR | Pressure,15-20 mmHg | In distribution |
| 12AR | Pressure,15-20 mmHg | In distribution |
| 12BK | Pressure,15-20 mmHg | In distribution |
| 12HD | Pressure,15-20 mmHg | In distribution |
| 12BK | Pressure,15-20 mmHg | In distribution |
| 12AR | Pressure,15-20 mmHg | In distribution |
| 12TH | Pressure,15-20 mmHg | In distribution |
| 12BK | Pressure,15-20 mmHg | In distribution |
| 12TH | Pressure,15-20 mmHg | In distribution |
| 12BK | Pressure,15-20 mmHg | In distribution |
| 12TM | Pressure,15-20 mmHg | In distribution |
| 12DG | Pressure,15-20 mmHg | In distribution |
| 12GL | Pressure,15-20 mmHg | In distribution |
| 12TM | Pressure,15-20 mmHg | In distribution |
| 12BK | Pressure,15-20 mmHg | In distribution |
| 12TH | Pressure,15-20 mmHg | In distribution |
| 12BK | Pressure,15-20 mmHg | In distribution |
| 12BK | Pressure,15-20 mmHg | In distribution |
| 12BK | Pressure,15-20 mmHg | In distribution |
| 12AR | Pressure,15-20 mmHg | In distribution |
| 12TH | Pressure,15-20 mmHg | In distribution |
| 12AR | Pressure,15-20 mmHg | In distribution |
| 12TH | Pressure,15-20 mmHg | In distribution |
| 12BK | Pressure,15-20 mmHg | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medi | Medi Manufacturing Inc | 752 |
| Solidea | Calzificio Pinelli SRL | 129 |
| Juzo Compression Wrap | Julius Zorn, Inc. | 117 |
| CompreFLEX | Sigvaris, Inc. | 82 |
| 11 CompreFit | Sigvaris, Inc. | 78 |
| 21 CoolFlex | Sigvaris, Inc. | 56 |
| 14 CompreFlex Arm | Sigvaris, Inc. | 44 |
| Jobst Bella | BSN Medical, Inc. | 32 |
| Bella Lite Glove | BSN Medical, Inc. | 32 |
| Juzo Custom Compression Garments | Julius Zorn, Inc. | 29 |
| 14 CompreFlex Knee | Sigvaris, Inc. | 28 |
| Jobst Relax | BSN-Jobst Gmbh | 24 |
Showing 12 of 355. All products under Binder, Medical, Therapeutic
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.