LineLogic™ - Sterile, Linelogic™ 7 Fr Catheter Stabilization - SMD Manufacturing LLC

Duns Number:070849038

Device Description: Sterile, Linelogic™ 7 Fr Catheter Stabilization Device

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More Product Details

Catalog Number

-

Brand Name

LineLogic™

Version/Model Number

LL-M-7

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)

-

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

KMK

Product Code Name

Device, Intravascular Catheter Securement

Device Record Status

Public Device Record Key

7d870eff-da61-4816-9467-efe17a0289a4

Public Version Date

August 09, 2022

Public Version Number

1

DI Record Publish Date

August 01, 2022

Additional Identifiers

Package DI Number

10851780008109

Quantity per Package

10

Contains DI Package

00851780008102

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"SMD MANUFACTURING LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1