Nomad PMU800 Portable Recorder (USB) N11133

GUDID 00817111021141

Nomad PMU800 Portable Recorder (USB)

NEUROTRONICS, INC.

Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system
Primary Device ID00817111021141
NIH Device Record Keya0c9435e-b342-4641-9fb9-570756fa38f2
Commercial Distribution StatusIn Commercial Distribution
Brand NameNomad PMU800 Portable Recorder (USB)
Version Model NumberPMU800
Catalog NumberN11133
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
GS100817111021141 [Primary]

FDA Product Code

DQAOximeter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-09
Device Publish Date2019-05-01

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