Duns Number:961027315
Device Description: Cardinal Health Isolation Gown Universal Over-the-head Elastic Wrist Thumbhooks Yellow Thi Cardinal Health Isolation Gown Universal Over-the-head Elastic Wrist Thumbhooks Yellow This gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate materials. Not intended for use in the operating room. This gown is classified as Level 2 per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.
Catalog Number
AT4498-BD
Brand Name
CARDINAL HEALTH
Version/Model Number
AT4498-BD
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
5dd51980-7b8f-4c7e-ae07-4cfdd05fed46
Public Version Date
August 12, 2019
Public Version Number
2
DI Record Publish Date
August 02, 2019
Package DI Number
50885380151734
Quantity per Package
10
Contains DI Package
20885380151733
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 |