Duns Number:081057389
Device Description: AERO CHROME* Breathable Performance Surgical Gown with Towel in Overwrap, XL
Catalog Number
44671NS
Brand Name
Halyard
Version/Model Number
44671
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FYA
Product Code Name
GOWN, SURGICAL
Public Device Record Key
c7dc5ab1-ff45-48d4-aece-dc228e469f61
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
October 02, 2019
Package DI Number
30680651446719
Quantity per Package
12
Contains DI Package
20680651446712
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1044 |