Serenity RIP01 RIP Belt, Medium - 21"-45" S13421

GUDID 00817111020946

Serenity RIP01 RIP Belt, Medium - 21"-45"

NEUROTRONICS, INC.

Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph Polysomnograph
Primary Device ID00817111020946
NIH Device Record Key4e2a4635-4112-4798-973a-80efe357605a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSerenity RIP01 RIP Belt, Medium - 21"-45"
Version Model NumberRIP01
Catalog NumberS13421
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
GS100817111020946 [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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