INVOS

Basic Information

• Brand Name: INVOS
• Primary DI: 10884521780163
• Version / Model: PMAC71RSC-L-CH4
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-31
• Public Version: 3
• Public Version Date: 2023-07-11
• Public Version Status: Update
• Public Device Record Key: 91e30e2a-be47-4525-a436-bd67261369e9

Device Description

Reusable Sensor Cable for 5100C, Channel 4

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MUD	Oximeter, tissue saturation	Cardiovascular	870.2700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47487	Electrical-only medical device connection cable, reusable	A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884521780163	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K182868	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 47 – 108 KiloPascal
• Type: Handling Environment Temperature
• Temperature Range: 16 – 32 Degrees Celsius
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Storage Environment Temperature
• Temperature Range: -4 – 113 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Humidity
• Temperature Range: 20 – 80 Percent (%) Relative Humidity