Integrity Sterilizers
Integrity 175 Vacuum/Gravity Steam Sterilizer, 17.5"W x 17.5"H x 26.5"D, Vertical Power Sliding Door w/ Foot Pedal Control, Water Ejector Vacuum System, House Steam, 120 Volt
3manufacturers in China registered for this device type
11catalogue numbers in this listing
1recall
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 | Skytron, LLC, United States |
|---|---|
| FDA product code | FLE |
| Device type | Sterilizer, Steam |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6880 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K132439 |
| Record published | 2016-09-19 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature 14 to 104 °F; Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment humidity 30 to 90 % RH; Handling environment humidity 30 to 90 % RH; Special storage condition: No Condensation; Handling environment temperature 14 to 104 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| INTEGRITY 270 | In distribution | |
| INTEGRITY 270VP | In distribution | |
| INTEGRITY 215 | In distribution | |
| 270-CR | In distribution | |
| 270-LC | In distribution | |
| INTEGRITY 175SG | In distribution | |
| 215-CR | In distribution | |
| 215-LC-CONV | In distribution | |
| 215-LC | In distribution | |
| INTEGRITY 175 | In distribution | |
| INTEGRITY 215SG | 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 |
| Midmark | Midmark Corporation | 21 |
| Bravo 17V Autoclave | Scican Ltd. | 19 |
| Atlas | Steris Mexico, S. de R.L. de C.V. | 18 |
Showing 12 of 119. All products under Sterilizer, Steam
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 |
|---|---|---|---|---|---|---|---|
| Skytron, LLC | 510(k) number | 2019-04-18 | Class II | Device Design | Weld attaching the air heater assembly to the main sterilizer unit has shown signs of fatigue/failure | 5 units | 2020-04-17 |
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.