Home GUDID 00849686070682 Nonin
Primary DI 00849686070682
Brand Nonin
Company NONIN MEDICAL, INC.
Model 8003CA
Device description Single-Patient Use, Non-Sterile, Disposable Regional Oximetry Sensor with EQUANOX™ Technology
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 true 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 00849686070682 Package GS1 20 In Commercial Distribution 00849686073195 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 00849686070682 00849686070682 849686070682 0849686070682 00849686073195 00849686073195 849686073195 0849686073195
GMDN Terms# Term, Definition table Term Definition Cerebral oximeter sensor, single-use A photoelectric device designed to be applied externally to the scalp/head of a patient for transcutaneous measurement [e.g., using near-infrared spectroscopy (NIRS)] of brain tissue blood oxygen saturation and/or venous oxygen saturation in the brain. It connects to a cerebral oximeter via a fibreoptic cable and typically consists of a single/dual adhesive sensing strip. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition 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 true Serial number false Manufacturing date on label false Expiration date on label true 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
Other Devices Sharing Product Codes# 
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