Duns Number:025460908
Device Description: DIALYSIS OFF KIT
Catalog Number
DT20350A
Brand Name
Medline Industries, Inc.
Version/Model Number
DT20350A
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"
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
PEV
Product Code Name
Dialysis administration kit
Public Device Record Key
968a5e7a-6479-4bf6-a45f-b67d1d49e6b6
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
February 07, 2021
Package DI Number
40193489435543
Quantity per Package
20
Contains DI Package
10193489435542
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |