FDA.reportPublic FDA data

INVOS

Primary DI
10884521780729
Brand
INVOS
Company
Covidien LP
Model
PMC71V-GE
Device description
GE CARESCAPE (TM) rSO2 - INVOS Parameter;For use with GE Patient Monitors
Published
2021-01-28
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
K182868000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182868000INVOS PM7100 Patient Monitor, INVOS Adult rSO2 SensorCovidien, LLC2019-01-08MUD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521780729PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452178072910884521780729

GMDN Terms#

Term, Definition table
TermDefinition
Tissue saturation oximeterA mains electricity (AC-powered) photoelectric device that noninvasively calculates the percent oxygen saturation of haemoglobin in a volume of tissue (StO2) to assess the amount of oxygen delivered to that tissue, typically during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation. The device typically includes a monitor for data analysis and display, a light-transmitting cable, and a tissue-surface sensor.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure0.5 KiloPascal1.075 KiloPascal
Handling Environment Atmospheric Pressure50 KiloPascal107.5 KiloPascal
Handling Environment Atmospheric Pressure50 KiloPascal108 KiloPascal
Handling Environment Atmospheric Pressure62 KiloPascal108 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-40 Degrees Fahrenheit158 Degrees Fahrenheit
Handling Environment Temperature50 Degrees Fahrenheit95 Degrees Fahrenheit
Special Storage Condition, Specify00Fragile, Keep dry
Special Storage Condition, Specify00Fragile, Keep dry;
Storage Environment Atmospheric Pressure0.616 KiloPascal1.075 KiloPascal
Storage Environment Atmospheric Pressure50 KiloPascal108 KiloPascal
Storage Environment Atmospheric Pressure61.6 KiloPascal107.5 KiloPascal
Storage Environment Atmospheric Pressure62 KiloPascal108 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Fahrenheit158 Degrees Fahrenheit
Storage Environment Temperature50 Degrees Fahrenheit95 Degrees Fahrenheit
Storage Environment Temperature50 Degrees Fahrenheit96 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00643169694859TrailBlazer™AngledASC-014-0902016-10-22
00643169694866TrailBlazer™AngledASC-014-1352016-10-22
00643169694873TrailBlazer™AngledASC-014-1502016-10-22
00643169694880TrailBlazer™AngledASC-018-0902016-10-22
00643169694897TrailBlazer™AngledASC-018-1352016-10-22
00643169694903TrailBlazer™AngledASC-018-1502016-10-22
00643169694910TrailBlazer™AngledASC-035-0652016-10-22
00643169694927TrailBlazer™AngledASC-035-0902016-10-22
00643169694934TrailBlazer™AngledASC-035-1352016-10-22
00643169694941TrailBlazer™AngledASC-035-1502016-10-22
00763000004804TrailBlazer™ AngledASC-014-0902017-12-22
00763000004811TrailBlazer™ AngledASC-014-1352017-12-22
00763000004828TrailBlazer™ AngledASC-014-1502017-12-22
00763000004835TrailBlazer™ AngledASC-018-0902017-12-22
00763000004842TrailBlazer™ AngledASC-018-1352017-12-22
00763000004859TrailBlazer™ AngledASC-018-1502017-12-22
00763000004866TrailBlazer™ AngledASC-035-0652017-12-22
00763000004873TrailBlazer™ AngledASC-035-0902017-12-22
00763000004880TrailBlazer™ AngledASC-035-1352017-12-22
00763000004897TrailBlazer™ AngledASC-035-1502017-12-22

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