Duns Number:025460908
Device Description: NON-TUMESCENT PACK
Catalog Number
DYNJ56985A
Brand Name
Medline Industries, Inc.
Version/Model Number
DYNJ56985A
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
K993463,K993463
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
e70cb808-1462-4107-bea4-64f2efed4358
Public Version Date
June 17, 2022
Public Version Number
5
DI Record Publish Date
January 27, 2019
Package DI Number
40193489585064
Quantity per Package
7
Contains DI Package
10193489585063
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 |