Duns Number:961027315
Device Description: Isolation Gown Universal Size AAMI Level 2 Over-the-head Elastic Wrist + Thumbhook Yellow Isolation Gown Universal Size AAMI Level 2 Over-the-head Elastic Wrist + Thumbhook 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
AT4488-BD
Brand Name
CARDINAL HEALTH
Version/Model Number
AT4488-BD
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
e07c2331-39a6-4f56-8804-0f489e9b1271
Public Version Date
September 10, 2018
Public Version Number
4
DI Record Publish Date
October 20, 2017
Package DI Number
50885380152304
Quantity per Package
10
Contains DI Package
20885380152303
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 |