INVOS

Basic Information

• Brand Name: INVOS
• Primary DI: 10884521807433
• Version / Model: PMSENS71-P
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-19
• Public Version: 11
• Public Version Date: 2023-08-03
• Public Version Status: Update
• Public Device Record Key: 465c8f9e-f93d-4470-9d40-d59547c0ac27

Device Description

Pediatric rSO2 Sensor

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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
46620	Cerebral oximeter sensor, single-use	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10884521809789	GS1	PACK_OR_INNER_PACK	5	In Commercial Distribution
Primary	10884521807433	GS1
Package	20884521809786	GS1	CASE	2	In Commercial Distribution
Package	30884521809783	GS1	PALLET	2	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K182868	000
K211561	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Weight, range 4 to 40, kg;

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 47 – 108 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Humidity
• Temperature Range: 15 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 62 – 108 KiloPascal
• Type: Special Storage Condition, Specify
• Special Conditions: Do not immerse in any liquids, Transport Temp -10 deg. C to 50 deg. C up to 72 hours