ThermiSense - ThermiSense® Nasal Air Flow Pressure and Gas - SALTER LABS

Duns Number:022721133

Device Description: ThermiSense® Nasal Air Flow Pressure and Gas Sampling Cannula (Pediatric) with Thermistor

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More Product Details

Catalog Number

5754-7-7

Brand Name

ThermiSense

Version/Model Number

5754-7-7

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

K151874,K151874,K151874

Product Code Details

Product Code

BZQ

Product Code Name

Monitor, breathing frequency

Device Record Status

Public Device Record Key

31ef4b42-112e-445c-828b-537ca890f4ff

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

20607411000175

Quantity per Package

25

Contains DI Package

10607411000178

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"SALTER LABS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 865
2 A medical device with a moderate to high risk that requires special controls. 1134