MedSource Extension Set, 8" w/ NP Needle Free Connector - Extension Set, 8" w/ NP Needle Free Connector - MEDSOURCE INTERNATIONAL LLC

Duns Number:041674552

Device Description: Extension Set, 8" w/ NP Needle Free Connector

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More Product Details

Catalog Number

-

Brand Name

MedSource Extension Set, 8" w/ NP Needle Free Connector

Version/Model Number

MS-89991

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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"

-

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

LHI

Product Code Name

Set, I.V. Fluid Transfer

Device Record Status

Public Device Record Key

a2405861-5d0e-4a1d-a12e-1d6fcb1ef6ca

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 30, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDSOURCE INTERNATIONAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 498
2 A medical device with a moderate to high risk that requires special controls. 90