compower - Anesthesia Mask is intended to deliver anesthetic - XIAMEN COMPOWER MEDICAL TECH. CO., LTD

Duns Number:543482946

Device Description: Anesthesia Mask is intended to deliver anesthetic gases to patients. In addition, anesthes Anesthesia Mask is intended to deliver anesthetic gases to patients. In addition, anesthesia masks are also used to deliver air and/or oxygen. The mask is a Non-Sterile Product for single patient use.

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More Product Details

Catalog Number

-

Brand Name

compower

Version/Model Number

3-N#

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

BSJ

Product Code Name

Mask, Gas, Anesthetic

Device Record Status

Public Device Record Key

f4cc1b3d-bbdd-4c87-b9aa-541990589d35

Public Version Date

February 28, 2022

Public Version Number

1

DI Record Publish Date

February 19, 2022

Additional Identifiers

Package DI Number

16946430413328

Quantity per Package

200

Contains DI Package

06946430413321

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