SleepmateThermistor AirFlow - 90 cm - Thermistor Airflow - 90 cm - Ambu A/S

Duns Number:305682023

Device Description: Thermistor Airflow - 90 cm

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More Product Details

Catalog Number

814941-100

Brand Name

SleepmateThermistor AirFlow - 90 cm

Version/Model Number

814941-100

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

K922112

Product Code Details

Product Code

BZQ

Product Code Name

Monitor, breathing frequency

Device Record Status

Public Device Record Key

c33b526e-7452-4c0c-ac24-7acee7ff569d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AMBU A/S" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 309