Home GUDID 00833166002508 Nonin
Primary DI 00833166002508
Brand Nonin
Company NONIN MEDICAL, INC.
Model X-100
Device description SenSmart Universal Oximetry System
Published 2016-08-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name MUD Oximeter, Tissue Saturation
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MUD Oximeter, Tissue Saturation Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00833166002508 Package GS1 1 In Commercial Distribution 00849686066180 Package GS1 1 In Commercial Distribution 00849686066982 Package GS1 1 In Commercial Distribution 00849686086324 Package GS1 1 In Commercial Distribution 00849686073577 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00833166002508 00833166002508 833166002508 0833166002508 00849686066180 00849686066180 849686066180 0849686066180 00849686066982 00849686066982 849686066982 0849686066982 00849686086324 00849686086324 849686086324 0849686086324 00849686073577 00849686073577 849686073577 0849686073577
GMDN Terms# Term, Definition table Term Definition Cerebral oximeter A mains electricity (AC-powered) photoelectric device that noninvasively measures the brain tissue blood oxygen saturation and venous oxygen saturation in the brain. It is typically used as an adjunct monitor for the regional haemoglobin oxygen saturation of blood in the brain of a paediatric or adult patient. It uses a cerebral sensor(s) having a light source and photodiode detector that is/are placed on the scalp/head. Position-1 detector detects infrared light absorption of extracranial blood and position-2 detector detects infrared light absorption of cerebral blood. Cerebral oxygenation is calculated by subtracting the absorption measured at site 1 from that measured at site 2.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Humidity -22 Degrees Fahrenheit 158 Degrees Fahrenheit Storage Environment Temperature -30 Degrees Celsius 70 Degrees Celsius
Regulatory Flags# DUNS number 174959692 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00833166000597 Nonin SAL-T-CONN 2016-09-07 00849686072068 Nonin 9840AAT 2016-08-24 00849686072129 Nonin LS1R 2016-08-24 00849686072181 Nonin LS1-9R 2016-08-24 00849686072204 Nonin LS1R-9R 2016-08-24 00849686072600 Nonin Capno SW 2017-03-13 00849686074307 Nonin 9843 2016-08-24 00849686074482 Nonin 9840SA 2016-08-24 00849686071092 Nonin 9840AAT 2016-09-03 00849686072136 Nonin LS1 2016-08-24 00849686052367 MODEL 3150, WRIST-OX2, BLE 3150 2024-11-21 00849686051698 HANDHELD PULSE OXIMETER 8500, PULSE OXIMETER 2024-09-17 00849686065855 HANDHELD PULSE OXIMETER 2500C, PULSE OXIMETER CHARGER 2024-09-17 00849686066524 Reusable Finger Clip Pulse Oximetry Sensors 8000AA, FINGER CLIP SENSOR 1M 2024-09-17 00849686070637 RESUSABLE PULSE OXIMETRY SENSOR SYSTEM 8100Q2, REUSABLE EAR CLIP SENSOR 2024-09-17 00849686085976 REUSABLE PULSE OXIMETRY SOFT SENSORS 70276, MODEL 8000JFW ADULT FLEXW DISP 2024-09-17 00833166000122 PALMSAT HANDHELD OXIMETER 2500,8000SM 2024-09-10 00833166000139 PALMSAT HANDHELD OXIMETER 2500, 8000SM-3 2024-09-10 00833166000146 PALMSAT HANDHELD OXIMETER 2500, 8000SL 2024-09-10 00833166004410 RESUSABLE PULSE OXIMETRY SENSOR SYSTEM EMBLA 8000J 3M 2024-09-10
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