Nellcor

Basic Information

• Brand Name: Nellcor
• Primary DI: 20884521617466
• Version / Model: FLEXMAX-HC
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-29
• Public Version: 6
• Public Version Date: 2021-11-10
• Public Version Status: Update
• Public Device Record Key: 42e9dcbc-2098-4922-8698-b1f4665a2366

Device Description

Flexible SpO2 Sensor, Reusable Homecare

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: Yes
• Has Lot/Batch Number: No
• 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
37808	Pulse oximeter probe, reusable	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. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10884521617469	GS1	CASE	20	In Commercial Distribution
Primary	20884521617466	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K162014	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Weight, >20, KG;

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: .62 – 1.06 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 15 – 95 Percent (%) Relative Humidity
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry
• Type: Handling Environment Temperature
• Temperature Range: 32 – 104 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: -40 – 158 Degrees Fahrenheit