Duns Number:112164780
Device Description: GOWN ISOLATION SMS W/ HOOK LOOP CLOSURE UNIVERSAL YELLOW ELASTIC WRIST LATEX FREE NON-STER GOWN ISOLATION SMS W/ HOOK LOOP CLOSURE UNIVERSAL YELLOW ELASTIC WRIST LATEX FREE NON-STERILE
Catalog Number
2150PG
Brand Name
CARDINAL HEALTH
Version/Model Number
2150PG
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
June 02, 2023
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
99a15a11-e050-404a-b4f6-573f118fe039
Public Version Date
July 01, 2021
Public Version Number
2
DI Record Publish Date
May 29, 2019
Package DI Number
50885380097735
Quantity per Package
4
Contains DI Package
20885380097734
Package Discontinue Date
June 02, 2023
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 |