Streamline Airless System Set with Locksite Needleless Access Sites and SecureCl - MEDISYSTEMS CORPORATION

Duns Number:061310132

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More Product Details

Catalog Number

-

Brand Name

Streamline Airless System Set with Locksite Needleless Access Sites and SecureCl

Version/Model Number

SL-2011M2098

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 28, 2020

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

FJK

Product Code Name

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Device Record Status

Public Device Record Key

3022a254-1ef2-46f0-af74-bd76315c3c2b

Public Version Date

September 29, 2020

Public Version Number

4

DI Record Publish Date

September 01, 2015

Additional Identifiers

Package DI Number

M535SL2011M20985

Quantity per Package

32

Contains DI Package

M535SL2011M20980

Package Discontinue Date

September 28, 2020

Package Status

Not in Commercial Distribution

Package Type

-

"MEDISYSTEMS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 167