Duns Number:023904428
Device Description: IV START KIT, TEGADERM™ DRESSING PVP PREP PAD
Catalog Number
-
Brand Name
McKesson
Version/Model Number
25-5862
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
-
Product Code
LRS
Product Code Name
I.V. Start Kit
Public Device Record Key
12068cc3-a011-4bae-964d-8d6a8434bb23
Public Version Date
December 11, 2019
Public Version Number
3
DI Record Publish Date
October 23, 2017
Package DI Number
40612479182224
Quantity per Package
50
Contains DI Package
10612479182216
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 | 870 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 422 |
| U | Unclassified | 44 |