Duns Number:134472476
Device Description: AAMI LEVEL 4 ISOLATION GOWN, POLYETHYLENE, THUMB LOOP, XL SIZE
Catalog Number
400623
Brand Name
Regard™
Version/Model Number
A4ISOGXLNS3-REG
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
b5034881-976c-4601-b992-6182b6a25360
Public Version Date
September 25, 2020
Public Version Number
1
DI Record Publish Date
September 17, 2020
Package DI Number
10326053117777
Quantity per Package
50
Contains DI Package
00326053117770
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 305 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 558 |