FDA.reportPublic FDA data

Nonin

Primary DI
00849686073577
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

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
00833166002508PackageGS11In Commercial Distribution
00849686066180PackageGS11In Commercial Distribution
00849686066982PackageGS11In Commercial Distribution
00849686086324PackageGS11In Commercial Distribution
00849686073577PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00833166002508008331660025088331660025080833166002508
00849686066180008496860661808496860661800849686066180
00849686066982008496860669828496860669820849686066982
00849686086324008496860863248496860863240849686086324
00849686073577008496860735778496860735770849686073577

GMDN Terms#

Term, Definition table
TermDefinition
Cerebral oximeterA 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
TypeLowHighCondition
Storage Environment Humidity-22 Degrees Fahrenheit158 Degrees Fahrenheit
Storage Environment Temperature-30 Degrees Celsius70 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
174959692
Device count
1
Serial number
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

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