Duns Number:080361159
Device Description: GOWN, ISOLATION AAMI LEVEL 2, OVER THE HEAD, 3XLARGE, YELLOW, FULL BACK, TIE WAIST, THUMBH GOWN, ISOLATION AAMI LEVEL 2, OVER THE HEAD, 3XLARGE, YELLOW, FULL BACK, TIE WAIST, THUMBHOOK W/ELASTIC WRIST, 10EA/BG, 10BG/CS (100EA/CS)
Catalog Number
-
Brand Name
ASP MEDICAL
Version/Model Number
GNA453L2
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)
Yes
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
f79d08a5-35fd-4e42-a602-a1bc5dffd96f
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
April 08, 2022
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 | 1046 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |
| U | Unclassified | 2 |