Duns Number:025460908
Device Description: H.C.R. ADMISSION KIT
Catalog Number
DYKA1235
Brand Name
Medline Industries, Inc.
Version/Model Number
DYKA1235
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
K001872,K001872
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
e3a6cba1-5647-44af-87b3-541e54660879
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
July 27, 2021
Package DI Number
40889942501916
Quantity per Package
10
Contains DI Package
10889942501915
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 |