Duns Number:047025993
Device Description: Transfer Blankets with Handles Royal Blue and Baby Blue
Catalog Number
-
Brand Name
VIVE
Version/Model Number
LVA2000BLU
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
IKX
Product Code Name
Aid, Transfer
Public Device Record Key
c896c245-5140-409f-854d-791ef51ca0ca
Public Version Date
October 19, 2021
Public Version Number
2
DI Record Publish Date
March 24, 2019
Package DI Number
10818323027324
Quantity per Package
20
Contains DI Package
00818323027327
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 |