compower - Cardiopulmonary resuscitation kit contains CPR - XIAMEN COMPOWER MEDICAL TECH. CO., LTD

Duns Number:543482946

Device Description: Cardiopulmonary resuscitation kit contains CPR Mask without Oxygen Port, two pieces alcoho Cardiopulmonary resuscitation kit contains CPR Mask without Oxygen Port, two pieces alcohol pads and one pair Nitril glove. CPR Mask without Oxygen Port is designed for mouth to mask ventilation to health emergency patients requiring cardiopulmonary resuscitator (CPR) rescue techniques of a non-breathing patient. It also functions as a barrier that will direct expired air from the patient away from the user. It is intended for over the counter use.

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More Product Details

Catalog Number

-

Brand Name

compower

Version/Model Number

CP641002+2A+NG

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)

-

Over the Counter (OTC)

Yes

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

1c0b4ac9-c155-4ec7-88eb-0c18da7f6613

Public Version Date

August 21, 2019

Public Version Number

2

DI Record Publish Date

February 28, 2018

Additional Identifiers

Package DI Number

16946430400458

Quantity per Package

60

Contains DI Package

06946430400451

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