Ventilator - ASSEMBLY, 3-LITER RESERVOIR KIT - Zoll Medical Corporation

Duns Number:055363428

Device Description: ASSEMBLY, 3-LITER RESERVOIR KIT

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Ventilator

Version/Model Number

704-0004-00

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

K162832

Product Code Details

Product Code

CBK

Product Code Name

VENTILATOR, CONTINUOUS, FACILITY USE

Device Record Status

Public Device Record Key

bddb3835-e0f4-4e26-a5fe-5bd170707abc

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

March 25, 2018

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