Vermed - IP Set ECG Adapter Cable - GRAPHIC CONTROLS ACQUISITION CORP

Duns Number:002111896

Device Description: IP Set ECG Adapter Cable

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More Product Details

Catalog Number

4009884C

Brand Name

Vermed

Version/Model Number

IPC72889

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

-

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

K101685

Product Code Details

Product Code

DSA

Product Code Name

Cable, Transducer And Electrode, Patient, (Including Connector)

Device Record Status

Public Device Record Key

daea00e7-ce19-4c73-9f7f-0a501336e7a8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 03, 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