Duns Number:007941230
Device Description: Clincial Use Only Combo No Disposable/Sngle Use ETO Sterilized FDA Class II Kit Yes M Clincial Use Only Combo No Disposable/Sngle Use ETO Sterilized FDA Class II Kit Yes Medical Device-Tax No MRI Safey Info Not Nat Rubber Ltx Prescription Use RX Sterile
Catalog Number
-
Brand Name
Medichoice
Version/Model Number
CLC2005A
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)
Yes
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
3790359d-96ba-4abe-86fb-9bb8bae1edf1
Public Version Date
October 06, 2020
Public Version Number
4
DI Record Publish Date
August 23, 2016
Package DI Number
20885632146678
Quantity per Package
30
Contains DI Package
10885632146671
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 |