Vermed - Electrocardiographic recording paper - GRAPHIC CONTROLS ACQUISITION CORP

Duns Number:002111896

Device Description: Electrocardiographic recording paper

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More Product Details

Catalog Number

30999174

Brand Name

Vermed

Version/Model Number

SCH 2.157-012A

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

DSF

Product Code Name

Recorder, Paper Chart

Device Record Status

Public Device Record Key

dabde229-bce6-47d9-bbb1-b7f8f5bf4f51

Public Version Date

October 24, 2018

Public Version Number

1

DI Record Publish Date

September 23, 2018

Additional Identifiers

Package DI Number

50009336001359

Quantity per Package

10

Contains DI Package

00009336001354

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