PBM Cardiac Marker Control - PBM Cardiac Marker Control Set (2 x 1 mL) - PRINCETON BIOMEDITECH CORPORATION

Duns Number:362917692

Device Description: PBM Cardiac Marker Control Set (2 x 1 mL)

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More Product Details

Catalog Number

LSC-300C-01

Brand Name

PBM Cardiac Marker Control

Version/Model Number

LSC-300C-01

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)

-

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

-

Product Code Name

-

Device Record Status

Public Device Record Key

633b3eaa-34cf-4417-8c66-450a95365e3b

Public Version Date

April 06, 2022

Public Version Number

1

DI Record Publish Date

March 29, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PRINCETON BIOMEDITECH CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 33
2 A medical device with a moderate to high risk that requires special controls. 92
U Unclassified 2