PoSAS

GUDID 00851113007758

PoSAS Desktop Software

ADVANCED BRAIN MONITORING, INC.

Medical equipment clinical data interfacing software
Primary Device ID00851113007758
NIH Device Record Keyb46a20c8-73f7-403c-80bc-d39d05de63e4
Commercial Distribution StatusIn Commercial Distribution
Brand NamePoSAS
Version Model NumberPS34-5401
Company DUNS969842715
Company NameADVANCED BRAIN MONITORING, 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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS100851113007758 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-11-08
Device Publish Date2018-03-19

Devices Manufactured by ADVANCED BRAIN MONITORING, INC.

00850063034005 - Apnea Guard2024-04-12 Apnea Guard Retention Material Kit 400g (OEM)
00850063034012 - Apnea Guard2024-04-12 Apnea Guard Starter Kit 1L3M1H (V2 OEM)
00850063034029 - Apnea Guard2024-04-12 Apnea Guard Starter Kit 2L2M1H (V2 OEM)
00850063034036 - Apnea Guard2024-04-12 Apnea Guard Starter Kit 1L2M2H (V2 OEM)
00850063034043 - Apnea Guard2024-04-12 Apnea Guard Starter Kit 1L3M6H (V2 OEM)
00850063034050 - Apnea Guard2024-04-12 Apnea Guard Resupply Kit 5L10M20H (V2 OEM)
00850015266966 - Sleep Profiler2024-03-22 Sleep Profiler LE Device Kit Swiss
00850015266973 - Sleep Profiler PSG22024-03-22 Sleep Profiler PSG2 LE Device Kit - Piezo (PVDF) Swiss

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.