Duns Number:025460908
Device Description: PD CATH KIT
Catalog Number
UVT1205
Brand Name
MEDLINE
Version/Model Number
UVT1205
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
OFD
Product Code Name
Catheter introducer kit
Public Device Record Key
d2e756be-f21b-4693-8e00-cad666f140a7
Public Version Date
April 12, 2022
Public Version Number
1
DI Record Publish Date
April 04, 2022
Package DI Number
00653160351828
Quantity per Package
5
Contains DI Package
10653160351825
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 |