Duns Number:007941230
Device Description: Device Blood Transfer With Male Luer Lock Connector Not Made With Natural Rubber Latex Cle Device Blood Transfer With Male Luer Lock Connector Not Made With Natural Rubber Latex Clear MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
BTD001
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
KST
Product Code Name
System, blood collection, vacuum-assisted, manual
Public Device Record Key
0f027ba7-88d5-40b5-8279-bd690f863155
Public Version Date
September 08, 2020
Public Version Number
1
DI Record Publish Date
August 31, 2020
Package DI Number
30885632136751
Quantity per Package
200
Contains DI Package
10885632136757
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 |