X SERIES - Defibrillator ,MAIN ASSY, X SERIES - Zoll Medical Corporation

Duns Number:055363428

Device Description: Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, S Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, SPCO, SPHB, SPOC, PVI&PI, IBP/TEMP CPR EXPANSION PACK AND ETCO2, DMST

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More Product Details

Catalog Number

-

Brand Name

X SERIES

Version/Model Number

610-2261511-01

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

K112432

Product Code Details

Product Code

CCK

Product Code Name

ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Device Record Status

Public Device Record Key

365cbff8-9d7c-42dc-ac05-58edacf0eed0

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 04, 2015

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