OXYGEN TUBE, 2.1M, NON PVC - OXYGEN TUBE, 2.1M, NON PVC - Intersurgical Incorporated

Duns Number:785952607

Device Description: OXYGEN TUBE, 2.1M, NON PVC

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More Product Details

Catalog Number

-

Brand Name

OXYGEN TUBE, 2.1M, NON PVC

Version/Model Number

1174010

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

Yes

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

4497c2ed-04a8-4211-8447-512218535ef8

Public Version Date

August 05, 2022

Public Version Number

3

DI Record Publish Date

October 11, 2021

Additional Identifiers

Package DI Number

05030267103133

Quantity per Package

100

Contains DI Package

05030267102747

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"INTERSURGICAL INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 222
2 A medical device with a moderate to high risk that requires special controls. 101