Duns Number:202659140
Device Description: The Flow Units are accessories that facilitate use of the Reliance EPS processor with spec The Flow Units are accessories that facilitate use of the Reliance EPS processor with specific endoscopes and endoscope accessory parts.
Catalog Number
EPSC010INT
Brand Name
NA
Version/Model Number
Flow Unit 10
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)
-
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
8576c328-3049-455a-a175-6baad42747df
Public Version Date
April 19, 2022
Public Version Number
11
DI Record Publish Date
April 15, 2017
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 |