Duns Number:025460908
Device Description: 3WAY LF CATHETER KIT
Catalog Number
DYNDA2544
Brand Name
MEDLINE
Version/Model Number
DYNDA2544
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FCN
Product Code Name
Urinary drainage collection kit, for indwelling catheter
Public Device Record Key
737f9fe9-f04e-4d1c-bf6e-307d45f2f15a
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
October 06, 2020
Package DI Number
20193489198253
Quantity per Package
20
Contains DI Package
10193489198256
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 |