Duns Number:788403103
Device Description: The AffloShield is a disposable gown intended for use with the AffloVest product line.
Catalog Number
8600
Brand Name
AffloShield
Version/Model Number
8600
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 24, 2022
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)
-
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
ac7a603d-47d4-4f19-b42b-3c075c122248
Public Version Date
February 25, 2022
Public Version Number
2
DI Record Publish Date
December 12, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |