Duns Number:007941230
Device Description: Tubing Suction 2 Connector Non-Conductive Heavy-Duty Durable Flexible With Male Adapter Po Tubing Suction 2 Connector Non-Conductive Heavy-Duty Durable Flexible With Male Adapter Polyvinyl Chloride 6 Feet X 0.25 Inch Sterile Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
Medichoice
Version/Model Number
ST2001
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
BYY
Product Code Name
TUBE, ASPIRATING, FLEXIBLE, CONNECTING
Public Device Record Key
c7c7a052-44c1-4e42-a5ce-dc2171c8df34
Public Version Date
October 21, 2020
Public Version Number
5
DI Record Publish Date
August 20, 2016
Package DI Number
50885632101005
Quantity per Package
50
Contains DI Package
10885632101007
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 |