ZOLL BATTERY LI-ION - BATTERY, LI-ION 9 CELL 18650, RECONDITIONED - Zoll Medical Corporation

Duns Number:055363428

Device Description: BATTERY, LI-ION 9 CELL 18650, RECONDITIONED

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More Product Details

Catalog Number

-

Brand Name

ZOLL BATTERY LI-ION

Version/Model Number

1009-001535-03-R

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

MKJ

Product Code Name

Automated external defibrillators (non-wearable)

Device Record Status

Public Device Record Key

cd0233a9-ceee-4387-9802-1b2989b9845f

Public Version Date

August 17, 2022

Public Version Number

1

DI Record Publish Date

August 09, 2022

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