FDA.reportPublic FDA data

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

Contact Domains#

Product Codes#

Code, Name table
CodeName
MUDOximeter, Tissue Saturation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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

Sterilization Methods#

Method table
Method

Contacts#

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

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 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884521845985INVOSCovidien LPMUD2025-07-03
20884521845036INVOSCovidien LPMUD2025-02-08
50690103211318ForeSightEdwards Lifesciences LLCMUD2024-08-26
50690103211325ForeSightEdwards Lifesciences LLCMUD2024-08-26
50690103211332ForeSightEdwards Lifesciences LLCMUD2024-08-26
10884521557048INVOSCovidien LPMUD2024-04-14
B376KD2050SnapshotNIRKent Imaging IncMUD2024-04-05
10884521824409INVOSCovidien LPMUD2023-11-03
10884521824416INVOSCovidien LPMUD2023-11-03
10884521832107INVOSCovidien LPMUD2023-05-11
00627987881806MIMOSAMIMOSA Diagnostics IncMUD2022-02-01
00690103208597FORESIGHT ELITEEdwards Lifesciences LLCMUD2021-11-10
00843997013888O3MASIMO CORPORATIONMUD2021-10-08
00843997014557O3MASIMO CORPORATIONMUD2021-10-08
10884521806436INVOSCovidien LPMUD2021-09-13
20884521810379INVOSCovidien LPMUD2021-08-27
20884521810362INVOSCovidien LPMUD2021-08-02
10884521809789INVOSCovidien LPMUD2021-06-19
20884521810102INVOSCovidien LPMUD2021-06-14
10884521810112INVOSCovidien LPMUD2021-06-14
10884521780729NellcorCovidien LPMUD2021-01-28
B376KD2040SnapshotNIRKent Imaging IncMUD2020-12-17
00843997013468O3MASIMO CORPORATIONMUD2020-09-03
00843997013499O3MASIMO CORPORATIONMUD2020-09-03
00690103208573HEMOSPHERE FORESIGHT MODULEEdwards Lifesciences LLCMUD2020-08-17
10843997012574O3MASIMO CORPORATIONMUD2020-07-03
50690103208110ForeSightEdwards Lifesciences LLCMUD2020-05-07
50690103208127ForeSightEdwards Lifesciences LLCMUD2020-05-07
50690103208134ForeSightEdwards Lifesciences LLCMUD2020-05-07
50690103208141ForeSightEdwards Lifesciences LLCMUD2020-05-07