Duns Number:047025993
Device Description: Shampoo Basin Blue
Catalog Number
-
Brand Name
VIVE
Version/Model Number
LVA2044
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ILS
Product Code Name
Adaptor, Hygiene
Public Device Record Key
d01e4a80-a6df-432c-91c7-b899d58722d6
Public Version Date
October 29, 2021
Public Version Number
2
DI Record Publish Date
March 19, 2020
Package DI Number
10810041981681
Quantity per Package
1
Contains DI Package
00810041981684
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 | 480 |
2 | A medical device with a moderate to high risk that requires special controls. | 87 |