Duns Number:961027315
Device Description: Isolation Gown; AAMI Level 3; Over-the-head; Elastic Wrist & Thumbhooks; Yellow; Universal
Catalog Number
AT6588-BD
Brand Name
CARDINAL HEALTH
Version/Model Number
AT6588-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"
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
FYC
Product Code Name
Gown, isolation, surgical
Public Device Record Key
867c3bfe-be30-4e9f-8273-a7144a781ba7
Public Version Date
February 22, 2022
Public Version Number
1
DI Record Publish Date
February 14, 2022
Package DI Number
50885380166646
Quantity per Package
10
Contains DI Package
20885380166645
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 |