SOL-M™ Holder with Male Luer Lock Adapter - SOL-M™ Tube Holder with Luer Lock Adapter - SOL-MILLENNIUM MEDICAL INC

Duns Number:069590113

Device Description: SOL-M™ Tube Holder with Luer Lock Adapter

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More Product Details

Catalog Number

-

Brand Name

SOL-M™ Holder with Male Luer Lock Adapter

Version/Model Number

110201050003

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

59e120a7-3b0d-4a4d-acac-82226d15bf80

Public Version Date

April 23, 2019

Public Version Number

4

DI Record Publish Date

July 03, 2018

Additional Identifiers

Package DI Number

20818392018152

Quantity per Package

4

Contains DI Package

10818392018155

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