SOL-CARE™ Safety Blood Collection Needle - SOL-CARE™ Safety Blood Collection Needle - SOL-MILLENNIUM MEDICAL INC

Duns Number:069590113

Device Description: SOL-CARE™ Safety Blood Collection Needle 25G*3/4*7inch (US)

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More Product Details

Catalog Number

-

Brand Name

SOL-CARE™ Safety Blood Collection Needle

Version/Model Number

110201030034

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

FPA

Product Code Name

Set, administration, intravascular

Device Record Status

Public Device Record Key

272dc275-fda2-4152-bd65-cce91b154cf6

Public Version Date

July 23, 2020

Public Version Number

4

DI Record Publish Date

June 26, 2018

Additional Identifiers

Package DI Number

20818392017292

Quantity per Package

4

Contains DI Package

10818392017295

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"SOL-MILLENNIUM MEDICAL INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 161