Duns Number:658318113
Device Description: Copioumed isolation gown made of non-woven material with open back. Features: Over-the-hea Copioumed isolation gown made of non-woven material with open back. Features: Over-the-head (OTH) neck style, elastic cuffs and ties for waist attachment.Each is a single-use over-the-head-style gown.
Catalog Number
-
Brand Name
Copioumed
Version/Model Number
IGN1Y7050-1
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
2efd41b5-c0d6-424e-8e4e-60fd0d1e24ce
Public Version Date
September 05, 2022
Public Version Number
1
DI Record Publish Date
August 26, 2022
Package DI Number
14719882250573
Quantity per Package
10
Contains DI Package
04719882250576
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 |