FDA.reportPublic FDA data

Nonin

Primary DI
00849686074758
Brand
Nonin
Company
NONIN MEDICAL, INC.
Model
8004CB
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
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MUDOximeter, Tissue Saturation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUDOximeter, Tissue SaturationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090807000
K132402000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090807000REGIONAL OXIMETER SYSTEM, MODEL 7600Nonin Medical, Inc.2009-06-30MUD
K132402000SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEMNonin Medical, Inc.2014-02-21DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00833166006810PackageGS120In Commercial Distribution
00849686070699PackageGS11In Commercial Distribution
00849686085792PackageGS110In Commercial Distribution
00849686074758PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00833166006810008331660068108331660068100833166006810
00849686070699008496860706998496860706990849686070699
00849686085792008496860857928496860857920849686085792
00849686074758008496860747588496860747580849686074758

GMDN Terms#

Term, Definition table
TermDefinition
Cerebral oximeter sensor, single-useA 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
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

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
Expiration 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
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyMUD2026-04-15
00690103219395Smart Pressure ControllerEdwards Lifesciences LLCMUD2025-09-10
00690103219531Acumen IQ PlusEdwards Lifesciences LLCMUD2025-09-10
00690103219609VitaWaveEdwards Lifesciences LLCMUD2025-09-10
00690103219616ForeSight IQEdwards Lifesciences LLCMUD2025-07-11
00690103217711Acumen AFM™ cable - HemoSphere Alta™ monitorEdwards Lifesciences LLCMUD2025-07-11
00690103217728HemoSphereEdwards Lifesciences LLCMUD2025-07-11
10884521845985INVOSCovidien LPMUD2025-07-03
00690103217957HemoSphere AltaEdwards Lifesciences LLCMUD2025-03-13
00690103217964HemoSphere AltaEdwards Lifesciences LLCMUD2025-03-13
00690103217971HemoSphere AltaEdwards Lifesciences LLCMUD2025-03-13
10884521845039INVOSCovidien LPMUD2025-02-08
20884521845036INVOSCovidien LPMUD2025-02-08
00690103218879HemoSphere VitaEdwards Lifesciences LLCMUD2024-08-28
00690103218886HemoSphere VitaEdwards Lifesciences LLCMUD2024-08-28
00690103211313ForeSightEdwards Lifesciences LLCMUD2024-08-26
00690103211320ForeSightEdwards Lifesciences LLCMUD2024-08-26
00690103211337ForeSightEdwards Lifesciences LLCMUD2024-08-26
50690103211318ForeSightEdwards Lifesciences LLCMUD2024-08-26
50690103211325ForeSightEdwards Lifesciences LLCMUD2024-08-26
50690103211332ForeSightEdwards Lifesciences LLCMUD2024-08-26
10884521701243INVOSCovidien LPMUD2024-04-14
10884521557048INVOSCovidien LPMUD2024-04-14
B376KD2050SnapshotNIRKent Imaging IncMUD2024-04-05
00690103217124HemoSphere VitaEdwards Lifesciences LLCMUD2024-02-26
00690103218848HemoSphere VitaEdwards Lifesciences LLCMUD2024-02-26
00690103218855HemoSphere VitaEdwards Lifesciences LLCMUD2024-02-26
00690103218862HemoSphere VitaEdwards Lifesciences LLCMUD2024-02-26
10884521824409INVOSCovidien LPMUD2023-11-03
10884521824416INVOSCovidien LPMUD2023-11-03