Nonin

Basic Information

• Brand Name: Nonin
• Primary DI: 00833166004083
• Version / Model: 6500MA
• 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: 2021-11-10
• Public Version Status: Update
• Public Device Record Key: 9be31c99-9b62-4c04-8b1e-737912d2da7c

Device Description

Single-Patient Use, Disposable Pulse Oximeter 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: No
• 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
DQA	Oximeter	Cardiovascular	870.2700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31658	Pulse oximeter probe, single-use	A photoelectric device designed to be applied externally to a body site (e.g., fingertip, ear lobe, bridge of nose, toe, or bridge of the foot) for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using signals produced by a light-emitting diode (LED) and received by a photodetector. The signals are subsequently transmitted to an oximeter/monitor (not included) which measures and displays the SpO2. The is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00833166001853	GS1	Bag	5	In Commercial Distribution
Primary	00833166004083	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K093306	000

Device Sizes

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -22 – 7158 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: -30 – 70 Degrees Celsius