Duns Number:830069063
Device Description: Isolation Gown, SMS AAMI Level 2, Yellow, X-Large, Elastic Cuff, Tie Waist, Neck Tab Closu Isolation Gown, SMS AAMI Level 2, Yellow, X-Large, Elastic Cuff, Tie Waist, Neck Tab Closure, Latex Free
Catalog Number
-
Brand Name
MH
Version/Model Number
3004XL
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
OEA
Product Code Name
Non-Surgical Isolation Gown
Public Device Record Key
8e70c101-1b5f-4282-939f-e7940ea98326
Public Version Date
September 23, 2020
Public Version Number
1
DI Record Publish Date
September 15, 2020
Package DI Number
10850018327722
Quantity per Package
5
Contains DI Package
00850018327725
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 | 9 |