Duns Number:007941230
Device Description: Connector Tubing Sims Tight Seal Sturdy Polyvinyl Chloride Non-Sterile Not Made With Natur Connector Tubing Sims Tight Seal Sturdy Polyvinyl Chloride Non-Sterile Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
CON1002
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
GCD
Product Code Name
CONNECTOR, CATHETER
Public Device Record Key
8b46e830-1f5d-4cb3-a54e-1f984eec4c2a
Public Version Date
June 08, 2021
Public Version Number
2
DI Record Publish Date
August 27, 2020
Package DI Number
50885632109384
Quantity per Package
10
Contains DI Package
30885632109380
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 |