Duns Number:961027315
Device Description: GOWN PLASTIC FILM THMBHKS XL BLUE
Catalog Number
5213PG
Brand Name
CARDINAL HEALTH
Version/Model Number
5213PG
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
58fb7d46-ba0e-4cb9-b659-df455d331740
Public Version Date
July 23, 2018
Public Version Number
2
DI Record Publish Date
June 06, 2018
Package DI Number
50885380134232
Quantity per Package
5
Contains DI Package
20885380134231
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 | 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 |