DISPOSABLE AIR CUSHION MASK W/HOOK VALVE SIZE#3 CHILD LARGE - DISPOSABLE AIR CUSHION MASK W/HOOK VALVE SIZE#3 - BESMED HEALTH BUSINESS CORP.

Duns Number:658023775

Device Description: DISPOSABLE AIR CUSHION MASK W/HOOK VALVE SIZE#3 CHILD LARGE

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More Product Details

Catalog Number

-

Brand Name

DISPOSABLE AIR CUSHION MASK W/HOOK VALVE SIZE#3 CHILD LARGE

Version/Model Number

CM-65134

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"

Yes

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

7a8f57ce-97eb-40fd-9a58-cd6285abb8a8

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 20, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BESMED HEALTH BUSINESS CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 289
2 A medical device with a moderate to high risk that requires special controls. 217