Duns Number:081057389
Device Description: HALYARD* Isolation Gown Non-AAMI Procedure Chemo, XX-Large
Catalog Number
37284-01
Brand Name
Halyard
Version/Model Number
37284
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
FYC
Product Code Name
GOWN, ISOLATION, SURGICAL
Public Device Record Key
f9aec700-0da5-4673-ac9f-7d7a39976008
Public Version Date
April 07, 2021
Public Version Number
5
DI Record Publish Date
June 08, 2017
Package DI Number
30680651372841
Quantity per Package
10
Contains DI Package
20680651372844
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 |