Respironics - Sensor Cable Holding Clips - Respironics Novametrix, LLC

Duns Number:093608594

Device Description: Sensor Cable Holding Clips

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More Product Details

Catalog Number

8751-00

Brand Name

Respironics

Version/Model Number

8751-00

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

OFP

Product Code Name

Anesthesia breathing circuit kit (adult & pediatric)

Device Record Status

Public Device Record Key

94ef0f51-9f2d-4209-a3c7-9126884a974e

Public Version Date

June 24, 2021

Public Version Number

2

DI Record Publish Date

September 14, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RESPIRONICS NOVAMETRIX, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 66
2 A medical device with a moderate to high risk that requires special controls. 61