Duns Number:190572854
Device Description: FMS Fluid Management System Outflow Tubing without One-Way valve (FMS VUE or FMS DUO Plus)
Catalog Number
284610
Brand Name
FMS
Version/Model Number
284610
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
Yes
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
K951843,K951843,K951843
Product Code
HRX
Product Code Name
ARTHROSCOPE
Public Device Record Key
26343c88-6b04-4667-8aff-3cbe5828e928
Public Version Date
April 23, 2019
Public Version Number
5
DI Record Publish Date
September 01, 2015
Package DI Number
30886705023220
Quantity per Package
12
Contains DI Package
10886705023226
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 560 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 479 |