OXYGEN TUBING, DISPOSABLE, W/25FT TUBE - OXYGEN TUBING, DISPOSABLE, W/25FT TUBE - BESMED HEALTH BUSINESS CORP.

Duns Number:658023775

Device Description: OXYGEN TUBING, DISPOSABLE, W/25FT TUBE

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More Product Details

Catalog Number

-

Brand Name

OXYGEN TUBING, DISPOSABLE, W/25FT TUBE

Version/Model Number

OT-83175

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

BYX

Product Code Name

Tubing, Pressure And Accessories

Device Record Status

Public Device Record Key

82c0f9d6-8ea1-43ab-bb16-4983f53aa2de

Public Version Date

August 05, 2022

Public Version Number

3

DI Record Publish Date

October 13, 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