Nonin

Basic Information

• Brand Name: Nonin
• Primary DI: 00849686074758
• Version / Model: 8004CB
• Company Name: NONIN MEDICAL, INC.
• Labeler DUNS: 174959692
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-24
• Public Version: 4
• Public Version Date: 2019-12-11
• Public Version Status: Update
• Public Device Record Key: 0c356c50-a1ff-47e2-b750-1fd7046868f5

Device Description

Single-Patient Use, Non-Sterile, Disposable Regional Oximetry Sensor with EQUANOX™ Technology

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: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• 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	00849686070699	GS1	Bag	1	In Commercial Distribution
Primary	00849686074758	GS1
Package	00833166006810	GS1	Box	20	In Commercial Distribution
Package	00849686085792	GS1	Box	10	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K090807	000
K132402	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Neonate
Device Size Text, specify			Infant
Device Size Text, specify			Pediatric

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -22 – 158 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: -30 – 70 Degrees Celsius