Duns Number:202659140
Device Description: The Reliance EPS Processor with base is intended for washing and high Level disinfection o The Reliance EPS Processor with base is intended for washing and high Level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-sensitive, semi-critical devices such as GI flexible endoscopes, bronchoscopes and their accessories.
Catalog Number
MB000078
Brand Name
Reliance
Version/Model Number
EPS
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 28, 2022
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K040049,K102244,K200989,K203223,K220361
Product Code
NZA
Product Code Name
Accessories, germicide, cleaning, for endoscopes
Public Device Record Key
a7b12b5f-38ad-4cb4-b135-02161d03ca81
Public Version Date
October 31, 2022
Public Version Number
4
DI Record Publish Date
September 04, 2020
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 | 58 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 262 |