Midmark
21 catalogue numbers from 9A599001, listed by Midmark Corporation, United States, under Sterilizer, Steam. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
21catalogue numbers in this listing
9510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Shanghai (1), Guangdong (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Guangzhou Ajax Medical Equipment Co Ltd | Guangzhou | Guangdong | Manufacturer | 13 |
| Ningbo Ican Machines Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 1 |
Record
| Listed by | Midmark Corporation, United States |
|---|---|
| FDA product code | FLE |
| Device type | Sterilizer, Steam |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6880 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K163337 |
| Record published | 2019-08-01 |
| Record revised | 2021-11-24 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 10 to 90 % RH; Storage environment temperature -30 to 60 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9A599001 | In distribution | |
| M11-041 / 9A682001 | In distribution | |
| M9-040 / 9A599001 | In distribution | |
| M9-041 / 9A682001 | In distribution | |
| M3-042 | In distribution | |
| M3-041 | In distribution | |
| M9-040 | In distribution | |
| M9-050 | In distribution | |
| M9-040R | In distribution | |
| M9-041 | In distribution | |
| M11-040 / 9A599001 | In distribution | |
| M3-040 | In distribution | |
| M11-041 / 9A599001 | In distribution | |
| M11-040 | In distribution | |
| M9-040 / 9A682001 | In distribution | |
| M11-050 | In distribution | |
| M9-041 / 9A599001 | In distribution | |
| M11-040R | In distribution | |
| 9A401002 | In distribution | |
| M11-051 | In distribution | |
| M11-041 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Amsco | Steris Mexico, S. de R.L. de C.V. | 434 |
| Getinge 500 Series | Getinge IC Production Poland sp. z o.o. | 133 |
| Getinge 700 Series | Getinge IC Production Poland sp. z o.o. | 82 |
| Aesculap | Aesculap AG | 67 |
| Getinge 600 Series | Getinge IC Production Poland sp. z o.o. | 61 |
| Sterilizer, Steam | Steris Mexico, S. de R.L. de C.V. | 53 |
| Getinge 800 Series | Getinge IC Production Poland sp. z o.o. | 41 |
| Getinge 400 Series | Getinge IC Production Poland sp. z o.o. | 37 |
| Primus Sterilizer | Primus Sterilizer Company, LLC. | 24 |
| Bravo 17V Autoclave | Scican Ltd. | 19 |
| Atlas | Steris Mexico, S. de R.L. de C.V. | 18 |
| Bravo 21V Autoclave | Scican Ltd. | 17 |
Showing 12 of 119. All products under Sterilizer, Steam
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233026 | 2024-04-04 |
| K163337 | 2017-08-31 |
| K090670 | 2009-07-07 |
| K023348 | 2003-03-03 |
| K992744 | 2000-01-10 |
| K990189 | 1999-04-19 |
| K936181 | 1994-11-30 |
| K911322 | 1991-08-26 |
| K900432 | 1990-07-27 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-10-24 | Not classified | Employee error | During and FDA inspection on 8/23/2011, it was discovered that the firm received numerous reports of the steam sterilizer malfunctioning. | 30,255 units | 2014-06-20 |
| 2003-03-05 | Not classified | Other | The pressure relief valve may fail to open properly. | 35 | 2004-01-20 |
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.