Duns Number:656854379
Catalog Number
Tube Clip 22mm
Brand Name
N/A
Version/Model Number
70065
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
JAY
Product Code Name
Support, Breathing Tube
Public Device Record Key
1bd07262-76d7-43df-91d5-6bbb01d70b26
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 15, 2015
Package DI Number
44710810115125
Quantity per Package
20
Contains DI Package
04710810115127
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 29 |
2 | A medical device with a moderate to high risk that requires special controls. | 22 |