Duns Number:012430880
Device Description: Isolation Gowns AAMI 3 Blue X-Large
Catalog Number
5702369
Brand Name
Essentials
Version/Model Number
5702369
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FYC
Product Code Name
Gown, isolation, surgical
Public Device Record Key
142f1215-1d61-42a8-8c62-51d1f9793c24
Public Version Date
June 02, 2021
Public Version Number
1
DI Record Publish Date
May 25, 2021
Package DI Number
20304040140257
Quantity per Package
10
Contains DI Package
10304040140250
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 | 3829 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2579 |
| 3 | A medical device with high risk that requires premarket approval | 1 |
| U | Unclassified | 34 |