Serenity BP01 Body Position Sensor, 1.5mm DIN, 2.0m S29724

GUDID 00817111020830

Serenity BP01 Body Position Sensor, 1.5mm DIN, 2.0m

NEUROTRONICS, INC.

Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph
Primary Device ID00817111020830
NIH Device Record Key39aad0a6-6e78-4adc-a57c-72cb48adda61
Commercial Distribution StatusIn Commercial Distribution
Brand NameSerenity BP01 Body Position Sensor, 1.5mm DIN, 2.0m
Version Model NumberBP01
Catalog NumberS29724
Company DUNS036405363
Company NameNEUROTRONICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817111020830 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLVStandard Polysomnograph With Electroencephalograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-10
Device Publish Date2018-11-08

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