Duns Number:958291411
Device Description: 2008 MeDS Pump Tubing Set
Catalog Number
04-7103-7
Brand Name
MeDS Pump
Version/Model Number
04-7103-7
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 06, 2019
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"
Yes
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
-
Product Code
KDI
Product Code Name
Dialyzer, high permeability with or without sealed dialysate system
Public Device Record Key
629e0797-cc56-46f7-bb90-4087b8c00790
Public Version Date
October 11, 2022
Public Version Number
4
DI Record Publish Date
September 30, 2015
Package DI Number
10840861100498
Quantity per Package
100
Contains DI Package
00840861100491
Package Discontinue Date
September 06, 2019
Package Status
Not in Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 65 |