Nellcor

Basic Information

• Brand Name: Nellcor
• Primary DI: 10884522042987
• Version / Model: DEC8
• 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: 4
• Public Version Date: 2022-08-31
• Public Version Status: Update
• Public Device Record Key: 30ffad5d-205a-4312-9476-606b5e334e56

Device Description

Sensor Extension Cable

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: 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
36092	Electrical mains power extension cable	An insulated electrical cord designed with a mains electricity supply plug at one end and single or multiple outlet socket clusters at the other end, intended to enable a connection between a medical device and a mains electricity supply. It is typically used where there is a need for many electrically-powered medical devices, e.g., in the operating room (OR). It is manufactured to medical grade standards for use in healthcare facilities and the home, providing the required legislative level of electrical safety; it may include an adaptor/transformer. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884522042984	GS1	CASE	50	In Commercial Distribution
Primary	10884522042987	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K012891	000

Device Sizes

Type	Value	Unit	Text
Length	8	Feet