Duns Number:961027315
Device Description: Isolation Gown Yellow X-Large AAMI Level 2
Catalog Number
VAT4437-XL
Brand Name
NOVAPLUS
Version/Model Number
VAT4437-XL
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 07, 2022
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OEA
Product Code Name
Non-surgical isolation gown
Public Device Record Key
c3d52b05-fbdc-4902-945d-6e265a82f729
Public Version Date
May 09, 2022
Public Version Number
3
DI Record Publish Date
August 02, 2019
Package DI Number
50885380151581
Quantity per Package
10
Contains DI Package
20885380151580
Package Discontinue Date
May 07, 2022
Package Status
Not 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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |