Catalog Number

-

Brand Name

SOL-CARE™ Safety Blood Collection Needle w/Pre-attached Holder

Version/Model Number

110201030010

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

JKA

Product Code Name

Tubes, vials, systems, serum separators, blood collection

Public Device Record Key

3561da37-fbfc-4279-ad1c-b547a34c1a7d

Public Version Date

July 23, 2020

Public Version Number

6

DI Record Publish Date

October 23, 2017

Package DI Number

20818392015625

Quantity per Package

8

Contains DI Package

10818392015628

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case