Duns Number:080935429
Device Description: Tube Holder,Removable Touch Fasten Strap
Catalog Number
31142667
Brand Name
Devon
Version/Model Number
31142667
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"
-
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
KGZ
Product Code Name
ACCESSORIES, CATHETER
Public Device Record Key
5991a642-123a-4a7e-9385-93a0208a7a4c
Public Version Date
February 15, 2019
Public Version Number
2
DI Record Publish Date
June 29, 2018
Package DI Number
10884527015825
Quantity per Package
100
Contains DI Package
30884527015829
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 | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |