Duns Number:062388929
Device Description: Isolation Gown, AAMI PB70 Level 2, yellow SMS, universal size, non-sterile, disposable, op Isolation Gown, AAMI PB70 Level 2, yellow SMS, universal size, non-sterile, disposable, open back, over the head, thumb loops, case of 100 each
Catalog Number
5241
Brand Name
Strong Manufacturers
Version/Model Number
5241
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
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
f3d18250-1c59-4a7e-a5bc-43f916964f24
Public Version Date
October 11, 2022
Public Version Number
1
DI Record Publish Date
October 03, 2022
Package DI Number
10850005354472
Quantity per Package
100
Contains DI Package
00850005354475
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 79 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |