Duns Number:961027315
Device Description: GOWN POLYCOATED THMBHKS XL BlUE
Catalog Number
4213PG
Brand Name
CARDINAL HEALTH
Version/Model Number
4213PG
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 18, 2021
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
bf03f8a7-9264-452a-957f-18e79848e49e
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
June 13, 2018
Package DI Number
50885380134218
Quantity per Package
10
Contains DI Package
30885380134214
Package Discontinue Date
February 18, 2021
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 |