Duns Number:830016148
Device Description: 3M™ Tegaderm™ Dressing Change IV Advanced Kit 25/Case 77-2100K01
Catalog Number
77-2100K01
Brand Name
Tegaderm™
Version/Model Number
77-2100K01
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
FRO
Product Code Name
Dressing, wound, drug
Public Device Record Key
5b4823e0-765b-43e4-83e8-5349fb9b45ba
Public Version Date
July 22, 2019
Public Version Number
5
DI Record Publish Date
October 13, 2016
Package DI Number
50707387772425
Quantity per Package
25
Contains DI Package
30707387772421
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 444 |
| U | Unclassified | 7 |