Onera STS ONERA STS1 HEAD ADHESIVE B

GUDID 08720256698098

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 ID08720256698098
NIH Device Record Key65c2745b-627e-45fa-9c36-bbdd77379fa2
Commercial Distribution StatusIn Commercial Distribution
Brand NameOnera STS
Version Model Number01.00
Catalog NumberONERA STS1 HEAD ADHESIVE B
Company DUNS492293557
Company NameOnera B.V.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
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

Length204.5 Millimeter
Width113 Millimeter
Height7 Millimeter
Length204.5 Millimeter
Width113 Millimeter
Height7 Millimeter
Length204.5 Millimeter
Width113 Millimeter
Height7 Millimeter
Length204.5 Millimeter
Width113 Millimeter
Height7 Millimeter
Length204.5 Millimeter
Width113 Millimeter
Height7 Millimeter
Length204.5 Millimeter
Width113 Millimeter
Height7 Millimeter
Length204.5 Millimeter
Width113 Millimeter
Height7 Millimeter
Length204.5 Millimeter
Width113 Millimeter
Height7 Millimeter
Length204.5 Millimeter
Width113 Millimeter
Height7 Millimeter
Length204.5 Millimeter
Width113 Millimeter
Height7 Millimeter
Length204.5 Millimeter
Width113 Millimeter
Height7 Millimeter
Length204.5 Millimeter
Width113 Millimeter
Height7 Millimeter
Length204.5 Millimeter
Width113 Millimeter
Height7 Millimeter
Length204.5 Millimeter
Width113 Millimeter
Height7 Millimeter
Length204.5 Millimeter
Width113 Millimeter
Height7 Millimeter
Length204.5 Millimeter
Width113 Millimeter
Height7 Millimeter
Length204.5 Millimeter
Width113 Millimeter
Height7 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
GS108720256698098 [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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