Sensor - External Flow Sensor, Adult / Pediatric - Respironics, Inc.

Duns Number:080728314

Device Description: External Flow Sensor, Adult / Pediatric

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More Product Details

Catalog Number

1134711

Brand Name

Sensor

Version/Model Number

External Flow Sensor, Adult/Ped

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

-

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

CBK

Product Code Name

VENTILATOR, CONTINUOUS, FACILITY USE

Device Record Status

Public Device Record Key

fee8d114-c691-4b1f-874b-29bc2413462b

Public Version Date

March 04, 2021

Public Version Number

3

DI Record Publish Date

May 08, 2019

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