All-Med, Inc. - 9.5" Standard Bore Bifurcated Extension Set with - ALL-MED INC

Duns Number:012789116

Device Description: 9.5" Standard Bore Bifurcated Extension Set with spike, pinch clamps and non-vented spike 9.5" Standard Bore Bifurcated Extension Set with spike, pinch clamps and non-vented spike ports. Lipid Resistant, Non-DEHP PVC, Latex Free. Approximate Priming Volume: 2.5ml

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More Product Details

Catalog Number

MB9SP

Brand Name

All-Med, Inc.

Version/Model Number

44-1903

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"

-

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

778c05b2-d5fb-486b-92a4-c4cda90dad2a

Public Version Date

August 10, 2018

Public Version Number

1

DI Record Publish Date

July 10, 2018

Additional Identifiers

Package DI Number

20816339022613

Quantity per Package

25

Contains DI Package

10816339022616

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"ALL-MED INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 156