Duns Number:831375089
Device Description: PremierPro Isolation Gown, AAMI 2, Yellow, Over Head, Full Back, Thumbloops, X-Large, 10/b PremierPro Isolation Gown, AAMI 2, Yellow, Over Head, Full Back, Thumbloops, X-Large, 10/bg
Catalog Number
D23467
Brand Name
PremierPro
Version/Model Number
D23467
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)
Yes
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
02e39f04-624e-4c02-b0a3-1e5edaac0dee
Public Version Date
January 24, 2022
Public Version Number
1
DI Record Publish Date
January 14, 2022
Package DI Number
00811220033637
Quantity per Package
12
Contains DI Package
00811220033606
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 | 486 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 177 |
| U | Unclassified | 1 |