Nellcor

Basic Information

• Brand Name: Nellcor
• Primary DI: 10884521159754
• Version / Model: 10083058
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2022-08-31
• Public Version Status: Update
• Public Device Record Key: 95146d69-17a1-478a-968f-a46cfa0ce4d5

Device Description

SpO2 Module Interface Cable not included;For use with Philips IntelliVue Patient Monitors.

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• 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
36554	Patient monitoring system module, pulse oximetry	A small unit dedicated to the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in blood using light detection methods (spectrophotometry) after light is emitted from a light-emitting diode (LED) situated in the connected probe. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the pulse oximetry parameters provided by this module.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884521159751	GS1	CASE	25	In Commercial Distribution
Primary	10884521159754	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K060576	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 11 – 107 KiloPascal
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 57 – 101 KiloPascal
• Type: Handling Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 15 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Humidity
• Temperature Range: 15 – 95 Percent (%) Relative Humidity