BIOSITE/BIOSITE PLUS - JR-018-LU Biosite Neonatal Extension Tube - Luer - MACLIN POWER, INC.

Duns Number:962650714

Device Description: JR-018-LU Biosite Neonatal Extension Tube - Luer Lock

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More Product Details

Catalog Number

JR-018-LU

Brand Name

BIOSITE/BIOSITE PLUS

Version/Model Number

JR-018-LU

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

93f7b692-9d4e-4d17-a1b2-3a17d5551294

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 14, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-