Duns Number:658318113
Device Description: Copioumed Heavy-Polyethylene Impervious Cover Gown with Thumb Loops offers excellent prote Copioumed Heavy-Polyethylene Impervious Cover Gown with Thumb Loops offers excellent protection against liquids and fluid exposure in infective wards, the ICU and emergency care. Each is a single-use over-the-head-style gown.
Catalog Number
-
Brand Name
Copioumed
Version/Model Number
PEN1B103-1
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
OEA
Product Code Name
Non-Surgical Isolation Gown
Public Device Record Key
99c08bf7-8aeb-4dee-8b17-695f5edae893
Public Version Date
September 08, 2022
Public Version Number
1
DI Record Publish Date
August 31, 2022
Package DI Number
14719882250559
Quantity per Package
5
Contains DI Package
04719882250552
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 |