Duns Number:007941230
Device Description: Tray Dressing Change MediChoice
Catalog Number
-
Brand Name
Medichoice
Version/Model Number
CLC1054
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
PEZ
Product Code Name
Central venous catheter dressing change kit
Public Device Record Key
b36c8a16-ee64-4a31-8e94-909cab499418
Public Version Date
October 06, 2020
Public Version Number
4
DI Record Publish Date
August 20, 2016
Package DI Number
50885632109131
Quantity per Package
30
Contains DI Package
10885632109133
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 | 428 |
2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
U | Unclassified | 1 |