Duns Number:025460908
Device Description: ISOLATION KIT
Catalog Number
DYKM1328
Brand Name
Medline Industries, Inc.
Version/Model Number
DYKM1328
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
KKX
Product Code Name
Drape, surgical
Public Device Record Key
5d854d57-1dc6-4566-b34f-6e9ae8500355
Public Version Date
June 17, 2022
Public Version Number
7
DI Record Publish Date
November 07, 2016
Package DI Number
40889942309925
Quantity per Package
20
Contains DI Package
10889942309924
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 |