BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

INVOS

DI: 10884521810372 · Model: CNN/SNN · Covidien LP

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Product Codes

1

GMDN Terms

1

Identifiers

3

Pkg Device Count

1

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Basic Information

Brand Name: INVOS
Primary DI: 10884521810372
Version / Model: CNN/SNN
Company Name: Covidien LP
Labeler DUNS: 058614483
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2021-08-27
Public Version: 13
Public Version Date: 2026-04-07
Public Version Status: Update
Public Device Record Key: c1b2fd51-0307-4309-8827-b61780f2af22

Device Description

OxyAlert NIRSensor Cerebral/Somatic - Neonatal

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: 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
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	20884521810379	GS1	PACK_OR_INNER_PACK	10	In Commercial Distribution
Primary	10884521810372	GS1
Package	30884521810376	GS1	CASE	8	In Commercial Distribution

Customer Contacts

Phone: +1(508)261-8000
Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Weight, less than 5, kg;

Storage Conditions

Type: Handling Environment Humidity
Temperature Range: 15 – 95 Percent (%) Relative Humidity
Type: Storage Environment Atmospheric Pressure
Temperature Range: 47 – 108 KiloPascal
Type: Storage Environment Temperature
Temperature Range: 10 – 30 Degrees Celsius
Type: Storage Environment Humidity
Temperature Range: 10 – 95 Percent (%) Relative Humidity
Type: Handling Environment Atmospheric Pressure
Temperature Range: 62 – 108 KiloPascal
Type: Handling Environment Temperature
Temperature Range: 10 – 35 Degrees Celsius