Impulse 7000DP - Defibrilator/AED Tester, External Pacer Analyzer - FLUKE ELECTRONICS CORPORATION

Duns Number:002687614

Device Description: Defibrilator/AED Tester, External Pacer Analyzer

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More Product Details

Catalog Number

2811919

Brand Name

Impulse 7000DP

Version/Model Number

IMPULSE 7000DP

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

-

Product Code Details

Product Code

DRL

Product Code Name

Tester, Defibrillator

Device Record Status

Public Device Record Key

d4d9a663-6037-4833-9d22-83c9fcb15861

Public Version Date

June 25, 2018

Public Version Number

1

DI Record Publish Date

May 24, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FLUKE ELECTRONICS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 21