Duns Number:069590113
Device Description: To enable withdrawal of blood samples from a patient. The device is designed to prevent ac To enable withdrawal of blood samples from a patient. The device is designed to prevent accidental needle stick injuries. The needle is retracted via a retraction tube.
Catalog Number
-
Brand Name
SOL-CARE™ Blood Collection Tube Holder Set
Version/Model Number
7001BCD
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
FMI
Product Code Name
Needle, hypodermic, single lumen
Public Device Record Key
32904e63-961f-4dca-a3bd-c6a9483ec1c3
Public Version Date
November 23, 2020
Public Version Number
6
DI Record Publish Date
September 16, 2016
Package DI Number
20818392012648
Quantity per Package
8
Contains DI Package
10818392012641
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 161 |