Duns Number:025460908
Device Description: DIALYSIS CHANGE KIT
Catalog Number
EBSI1453A
Brand Name
MEDLINE
Version/Model Number
EBSI1453A
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OXQ
Product Code Name
Dressing change tray
Public Device Record Key
a97bcf0a-9847-48eb-ac13-6a453111fe0e
Public Version Date
October 05, 2022
Public Version Number
1
DI Record Publish Date
September 27, 2022
Package DI Number
00653160355468
Quantity per Package
20
Contains DI Package
10653160355465
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 |