Nellcor

Basic Information

• Brand Name: Nellcor
• Primary DI: 10884522042529
• Version / Model: RS10
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-27
• Public Version: 6
• Public Version Date: 2023-04-07
• Public Version Status: Update
• Public Device Record Key: 30e064af-ab41-47c4-abd3-25d71433e657

Device Description

Forehead SpO2 Sensor

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: 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
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	30884522042523	GS1	CASE	3	In Commercial Distribution
Primary	10884522042529	GS1
Package	20884522042526	GS1	PACK_OR_INNER_PACK	6	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K904039	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Greater than, 40, kg;