PrImary Care by MDP™ - GRAPHIC CONTROLS ACQUISITION CORP

Duns Number:002111896

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More Product Details

Catalog Number

V8830

Brand Name

PrImary Care by MDP™

Version/Model Number

V8830

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"

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

DRX

Product Code Name

Electrode, Electrocardiograph

Device Record Status

Public Device Record Key

838a1d92-6354-42ca-b9a6-97e3fe434d25

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

20813150021726

Quantity per Package

40

Contains DI Package

10813150021729

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"GRAPHIC CONTROLS ACQUISITION CORP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 161
2 A medical device with a moderate to high risk that requires special controls. 269
3 A medical device with high risk that requires premarket approval 1