Duns Number:830016148
Device Description: 3M(TM) Tegaderm(TM) IV Adavanced Securement Dressing 1685
Catalog Number
1685
Brand Name
3M™ Tegaderm™
Version/Model Number
1685
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KMK
Product Code Name
DEVICE, INTRAVASCULAR CATHETER SECUREMENT
Public Device Record Key
dc52daa1-35ba-4fa3-8721-d4e19b535cb2
Public Version Date
December 22, 2021
Public Version Number
2
DI Record Publish Date
September 24, 2018
Package DI Number
50707387582772
Quantity per Package
4
Contains DI Package
04046719388202
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 |