Duns Number:961027315
Device Description: ISOLATION GOWN XL SMS BLUE NECK TIES LIGHTWEIGHT NONSTERILE
Catalog Number
2201PG
Brand Name
CARDINAL HEALTH
Version/Model Number
2201PG
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
November 04, 2024
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
e8d272ef-5888-4f09-8cc5-b6635eea8e32
Public Version Date
December 03, 2021
Public Version Number
2
DI Record Publish Date
August 22, 2019
Package DI Number
50885380136564
Quantity per Package
10
Contains DI Package
20885380136563
Package Discontinue Date
November 04, 2024
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 |