FDA.report

Nonin

Primary DI
00833166000658
Brand
Nonin
Company
NONIN MEDICAL, INC.
Model
3100I
Device description
Adapter Cable
Published
2016-09-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
DQAOximeter

Product Code Classifications

CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00833166000658PrimaryGS10

GMDN Terms

TermDefinition
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.

Sterilization Methods

Method

Contacts

PhoneEmail
763 553 9968Regulatory@nonin.com

Regulatory Flags

DUNS number
174959692
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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 DIBrandModelCatalogPublished
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
00833166009859FINGERTIP PULSE OXIMETER9590 BLUE, OXIMETER2024-09-10
00833166009866FINGERTIP PULSE OXIMETER9590 RED, OXIMETER 2024-09-10
00833166000054PALMSAT HANDHELD OXIMETER2500, 8001J2024-09-09
00849686050981WristOx2 Model 3150SC USB Comm Cable, Philips3150SC2021-04-05
00849686050998Soft Sensor Large WO2 Model 8000SL-WO28000SL-WO22021-04-05
00849686051001Soft Sensor Medium WO2 Model 8000SM-WO28000SM-WO22021-04-05
00849686051018Soft Sensor Small WO2 Model 8000SS-WO28000SS-WO22021-04-05
00849686051025WristOx2 Model 3150 with Bluetooth Low Energy31502021-04-05
00833166004113Nonin3150SC2016-09-03
00849686070972Nonin7500 Analog Cable2016-09-03

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