Vermed Holter Kit - Packed for Franklin County Heart Center25 KITS - GRAPHIC CONTROLS ACQUISITION CORP

Duns Number:002111896

Device Description: Packed for Franklin County Heart Center25 KITS PER CASE

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More Product Details

Catalog Number

FRAN09-01

Brand Name

Vermed Holter Kit

Version/Model Number

FRAN09-01

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 21, 2018

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

-

Product Code Name

-

Device Record Status

Public Device Record Key

4999c25f-3e85-4805-9080-4ba0ee128d3a

Public Version Date

August 22, 2018

Public Version Number

3

DI Record Publish Date

April 14, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

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