Duns Number:025460908
Device Description: KOSAIR INFANT CATH PACK
Catalog Number
00-401185P
Brand Name
Medline Industries, Inc.
Version/Model Number
00-401185P
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
-
Product Code
OES
Product Code Name
Cardiac catheterization kit
Public Device Record Key
4acb88fc-0df9-4538-8683-68bab6d1d9c7
Public Version Date
June 17, 2022
Public Version Number
4
DI Record Publish Date
November 07, 2016
Package DI Number
40884389902098
Quantity per Package
3
Contains DI Package
10884389902097
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 |