Duns Number:081057389
Device Description: HALYARD* Spunbond Isolation Gown with Elastic Cuffs, X-Large, Blue
Catalog Number
69129
Brand Name
Halyard
Version/Model Number
69129
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
OEA
Product Code Name
Non-surgical isolation gown
Public Device Record Key
6e8de367-6883-4685-9a9f-5f832823a933
Public Version Date
January 20, 2021
Public Version Number
1
DI Record Publish Date
January 12, 2021
Package DI Number
30680651691294
Quantity per Package
10
Contains DI Package
20680651691297
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 |