Duns Number:025460908
Device Description: NICU ADMIT KIT
Catalog Number
DYKA1014F
Brand Name
Medline Industries, Inc.
Version/Model Number
DYKA1014F
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
K003225,K003225
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
eda333f5-1279-44be-bcca-597700057d05
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
November 09, 2021
Package DI Number
40193489365703
Quantity per Package
6
Contains DI Package
10193489365702
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 |