Duns Number:658318113
Device Description: Copioumed’s Isolation Gown is intended to protect health care patients and health care per Copioumed’s Isolation Gown is intended to protect health care patients and health care personal from the transfer of microorganisms, body fluids and particulate material.Isolation Gown is a single use, disposable medical device provided non-sterile.
Catalog Number
-
Brand Name
Copioumed
Version/Model Number
IGN3Y1032-1
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
07bf22e1-30ad-422b-9fde-72d3ec9fdba2
Public Version Date
September 16, 2022
Public Version Number
1
DI Record Publish Date
September 08, 2022
Package DI Number
14719882250917
Quantity per Package
10
Contains DI Package
04719882250910
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |