Duns Number:020275145
Device Description: Kit, ViroMax, 24" Tubing, For Cosmed Bod Pod
Catalog Number
180013
Brand Name
Kit, ViroMax, 24" Tubing, For Cosmed Bod Pod
Version/Model Number
Kit, ViroMax, 24" Tubing - 180013
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
CAH
Product Code Name
Filter, Bacterial, Breathing-Circuit
Public Device Record Key
d9c96dc7-ad3c-4752-a4bb-a830d1741473
Public Version Date
March 22, 2019
Public Version Number
1
DI Record Publish Date
March 14, 2019
Package DI Number
00817081022421
Quantity per Package
50
Contains DI Package
00817081022414
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 222 |
2 | A medical device with a moderate to high risk that requires special controls. | 126 |