Circuit Tubing - Reusable Flexible Tubing, Grey - Respironics, Inc.

Duns Number:080728314

Device Description: Reusable Flexible Tubing, Grey

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More Product Details

Catalog Number

622038

Brand Name

Circuit Tubing

Version/Model Number

Reusable Flexible Tubing, Grey

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

-

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

3c2ba8e8-12a2-4621-862b-46b1f25ac714

Public Version Date

January 26, 2021

Public Version Number

4

DI Record Publish Date

June 09, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RESPIRONICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 151
2 A medical device with a moderate to high risk that requires special controls. 3279