FDA.reportPublic FDA data

Nonin

Primary DI
00833166003802
Brand
Nonin
Company
NONIN MEDICAL, INC.
Model
7600PA
Device description
7600 PA Regional
Published
2016-09-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
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

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090807000REGIONAL OXIMETER SYSTEM, MODEL 7600Nonin Medical, Inc.2009-06-30MUD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849686088786PackageGS11In Commercial Distribution
00833166003802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849686088786008496860887868496860887860849686088786
00833166003802008331660038028331660038020833166003802

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 Temperature-40 Degrees Celsius70 Degrees Celsius
Storage Environment Temperature-40 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

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00690103218862HemoSphere VitaEdwards Lifesciences LLCMUD2024-02-26
10884521824409INVOSCovidien LPMUD2023-11-03
10884521824416INVOSCovidien LPMUD2023-11-03