FDA.reportPublic FDA data

Nonin

Primary DI
00849686073560
Brand
Nonin
Company
NONIN MEDICAL, INC.
Model
X-100H
Device description
Hub
Published
2016-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQAOximeter
MUDOximeter, Tissue Saturation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2
MUDOximeter, Tissue SaturationCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00833166002218PackageGS11In Commercial Distribution
00849686073560PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00833166002218008331660022188331660022180833166002218
00849686073560008496860735608496860735600849686073560

GMDN Terms#

Term, Definition table
TermDefinition
Electrical cable/lead holderA device intended to hold medical cables/leads, primarily those that convey electricity and electrical signals. It is typically used in conjunction with an electrocardiograph (ECG) or an electromyograph (EMG) to support and stabilize electrical cable/leads used during patient treatment. It is typically designed as a jointed, adjustable arm with a mounting fixture, that attaches to the recording device, and a holder at the distal end to hold the cables/leads near the patient; it is intended to help organize and protect the cables/leads to prolong their life and help prevent patient disconnection. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-30 Degrees Celsius70 Degrees Celsius
Storage Environment Temperature-22 Degrees Fahrenheit158 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
763 553 9968Regulatory@nonin.com

Regulatory Flags#

DUNS number
174959692
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00833166000597NoninSAL-T-CONN2016-09-07
00849686072068Nonin9840AAT2016-08-24
00849686072129NoninLS1R2016-08-24
00849686072181NoninLS1-9R2016-08-24
00849686072204NoninLS1R-9R2016-08-24
00849686072600NoninCapno SW2017-03-13
00849686074307Nonin98432016-08-24
00849686074482Nonin9840SA2016-08-24
00849686071092Nonin9840AAT2016-09-03
00849686072136NoninLS12016-08-24
00849686052367MODEL 3150, WRIST-OX2, BLE31502024-11-21
00849686051698HANDHELD PULSE OXIMETER8500, PULSE OXIMETER2024-09-17
00849686065855HANDHELD PULSE OXIMETER2500C, PULSE OXIMETER CHARGER2024-09-17
00849686066524Reusable Finger Clip Pulse Oximetry Sensors8000AA, FINGER CLIP SENSOR 1M2024-09-17
00849686070637RESUSABLE PULSE OXIMETRY SENSOR SYSTEM8100Q2, REUSABLE EAR CLIP SENSOR2024-09-17
00849686085976REUSABLE PULSE OXIMETRY SOFT SENSORS70276, MODEL 8000JFW ADULT FLEXW DISP2024-09-17
00833166000122PALMSAT HANDHELD OXIMETER2500,8000SM2024-09-10
00833166000139PALMSAT HANDHELD OXIMETER2500, 8000SM-32024-09-10
00833166000146PALMSAT HANDHELD OXIMETER2500, 8000SL2024-09-10
00833166004410RESUSABLE PULSE OXIMETRY SENSOR SYSTEMEMBLA 8000J 3M2024-09-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20884838115389Nasal Alar SpO2 SensorPhilips Medizin Systeme Böblingen GmbHDQA2026-10-16
20884838115396Nasal Alar SpO2 SensorPhilips Medizin Systeme Böblingen GmbHDQA2026-10-16
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyMUD2026-10-04
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyDQA2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyDQA2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyMUD2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyMUD2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyDQA2026-10-04
06924054300586BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-04-22
06946725549926APKAPK Technology Co.,Ltd.DQA2026-03-19
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06946725513750APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513767APKAPK Technology Co.,Ltd.DQA2026-03-10