Duns Number:078375583
Device Description: I5 Washer Disinfector w/ dual automated doors 35.5"W x 33"D x 79"H, hot, cold and fil rins I5 Washer Disinfector w/ dual automated doors 35.5"W x 33"D x 79"H, hot, cold and fil rinse water, 2 chemical pumps, integrated dryer, drain cool down, 4 level rack, Selectable Steam/Electric, 208V
Catalog Number
I5-PT-SE
Brand Name
I-Series Washers
Version/Model Number
I5-PT-SE
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MEC
Product Code Name
Disinfector, medical devices
Public Device Record Key
abd0a86c-6fdd-47ba-a192-9fdad227f330
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 19, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 747 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 265 |