Compower - The intended use for Infant Disposable Manual - XIAMEN COMPOWER MEDICAL TECH. CO., LTD

Duns Number:543482946

Device Description: The intended use for Infant Disposable Manual Resuscitator: Single patient use manual resu The intended use for Infant Disposable Manual Resuscitator: Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital care to temporary ventilate a patient for the given body mass ranges of:Infant: less than or equal to 10Kg, Child: less than or equal to 23 Kg, Adult: greater than 23 Kg. It is for infant population. It is disposable.

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More Product Details

Catalog Number

-

Brand Name

Compower

Version/Model Number

NPVC-003/RTMA1

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

K210288,K210288

Product Code Details

Product Code

BTM

Product Code Name

Ventilator, Emergency, Manual (Resuscitator)

Device Record Status

Public Device Record Key

446a93df-8ad0-404a-887c-08bda16bccea

Public Version Date

September 23, 2021

Public Version Number

1

DI Record Publish Date

September 15, 2021

Additional Identifiers

Package DI Number

16946430410877

Quantity per Package

24

Contains DI Package

06946430410870

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