Duns Number:112164780
Device Description: ISOLATION GOWN UNIVERSAL PE FILM OVER THE HEAD THUMBLOOP LATEX FREE NONSTERILE BULK HALF B ISOLATION GOWN UNIVERSAL PE FILM OVER THE HEAD THUMBLOOP LATEX FREE NONSTERILE BULK HALF BACK
Catalog Number
5211PG
Brand Name
CARDINAL HEALTH
Version/Model Number
5211PG
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)
-
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
5fc8871c-7429-4dc6-8833-fb06754246e8
Public Version Date
March 18, 2020
Public Version Number
2
DI Record Publish Date
August 21, 2019
Package DI Number
50885380125780
Quantity per Package
4
Contains DI Package
30885380125786
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 | 81 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 111 |