Zulco International Inc - The cardiopulmonary resuscitation aid kit - XIAMEN COMPOWER MEDICAL TECH. CO., LTD

Duns Number:543482946

Device Description: The cardiopulmonary resuscitation aid kit comprises of one CPR mask with Oxygen Port, two The cardiopulmonary resuscitation aid kit comprises of one CPR mask with Oxygen Port, two pieces alcohol pads and one pair PVC glove. This kit is designed for mouth to mask ventilation to health emergency patients requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques of a non-breathing patient. It functions as a barrier to direct expired air from the patient away from the user. It can be used with supplemental oxygen when needed.

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More Product Details

Catalog Number

-

Brand Name

Zulco International Inc

Version/Model Number

CP641000+2A+PG

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

Yes

Prescription Use (Rx)

Yes

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

-

Product Code Name

-

Device Record Status

Public Device Record Key

1487ff49-f57a-42eb-8867-16c42d60e92f

Public Version Date

January 31, 2019

Public Version Number

1

DI Record Publish Date

December 31, 2018

Additional Identifiers

Package DI Number

16946430401295

Quantity per Package

60

Contains DI Package

06946430401298

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton

"XIAMEN COMPOWER MEDICAL TECH. CO., LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 34
2 A medical device with a moderate to high risk that requires special controls. 27