Onera STS ONERA STS1 FLOW

GUDID 08720256698050

Onera B.V.

Polysomnography analyser Polysomnography analyser Polysomnography analyser Polysomnography analyser Polysomnography analyser Polysomnography analyser Polysomnography analyser Polysomnography analyser Polysomnography analyser Polysomnography analyser Polysomnography analyser Polysomnography analyser Polysomnography analyser Polysomnography analyser Polysomnography analyser Polysomnography analyser Polysomnography analyser
Primary Device ID08720256698050
NIH Device Record Key23205201-d3ef-4729-95bd-c6d808251bb4
Commercial Distribution StatusIn Commercial Distribution
Brand NameOnera STS
Version Model Number01.00
Catalog NumberONERA STS1 FLOW
Company DUNS492293557
Company NameOnera B.V.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+31403082177
Emailinfo@onerahealth.com
Phone+31403082177
Emailinfo@onerahealth.com
Phone+31403082177
Emailinfo@onerahealth.com
Phone+31403082177
Emailinfo@onerahealth.com
Phone+31403082177
Emailinfo@onerahealth.com
Phone+31403082177
Emailinfo@onerahealth.com
Phone+31403082177
Emailinfo@onerahealth.com
Phone+31403082177
Emailinfo@onerahealth.com
Phone+31403082177
Emailinfo@onerahealth.com
Phone+31403082177
Emailinfo@onerahealth.com
Phone+31403082177
Emailinfo@onerahealth.com
Phone+31403082177
Emailinfo@onerahealth.com
Phone+31403082177
Emailinfo@onerahealth.com
Phone+31403082177
Emailinfo@onerahealth.com
Phone+31403082177
Emailinfo@onerahealth.com
Phone+31403082177
Emailinfo@onerahealth.com
Phone+31403082177
Emailinfo@onerahealth.com

Device Dimensions

Weight54 Gram
Height21 Millimeter
Length82 Millimeter
Width63.5 Millimeter
Weight54 Gram
Height21 Millimeter
Length82 Millimeter
Width63.5 Millimeter
Weight54 Gram
Height21 Millimeter
Length82 Millimeter
Width63.5 Millimeter
Weight54 Gram
Height21 Millimeter
Length82 Millimeter
Width63.5 Millimeter
Weight54 Gram
Height21 Millimeter
Length82 Millimeter
Width63.5 Millimeter
Weight54 Gram
Height21 Millimeter
Length82 Millimeter
Width63.5 Millimeter
Weight54 Gram
Height21 Millimeter
Length82 Millimeter
Width63.5 Millimeter
Weight54 Gram
Height21 Millimeter
Length82 Millimeter
Width63.5 Millimeter
Weight54 Gram
Height21 Millimeter
Length82 Millimeter
Width63.5 Millimeter
Weight54 Gram
Height21 Millimeter
Length82 Millimeter
Width63.5 Millimeter
Weight54 Gram
Height21 Millimeter
Length82 Millimeter
Width63.5 Millimeter
Weight54 Gram
Height21 Millimeter
Length82 Millimeter
Width63.5 Millimeter
Weight54 Gram
Height21 Millimeter
Length82 Millimeter
Width63.5 Millimeter
Weight54 Gram
Height21 Millimeter
Length82 Millimeter
Width63.5 Millimeter
Weight54 Gram
Height21 Millimeter
Length82 Millimeter
Width63.5 Millimeter
Weight54 Gram
Height21 Millimeter
Length82 Millimeter
Width63.5 Millimeter
Weight54 Gram
Height21 Millimeter
Length82 Millimeter
Width63.5 Millimeter

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108720256698050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNRVentilatory Effort Recorder

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-23
Device Publish Date2023-03-15

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0872025669800501.00

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