Cable - V-PAK ADAPTER CABLE - Zoll Medical Corporation

Duns Number:055363428

Device Description: V-PAK ADAPTER CABLE

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More Product Details

Catalog Number

-

Brand Name

Cable

Version/Model Number

9500-0315-01

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K062537

Product Code Details

Product Code

DRT

Product Code Name

MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)

Device Record Status

Public Device Record Key

88f90087-7609-410f-a6d1-e708284e8ba8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ZOLL MEDICAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10
2 A medical device with a moderate to high risk that requires special controls. 1473
3 A medical device with high risk that requires premarket approval 1032