Nellcor

Basic Information

• Brand Name: Nellcor
• Primary DI: 10884522042819
• Version / Model: FOAM P/I
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2018-09-26
• Public Version: 3
• Public Version Date: 2022-06-03
• Public Version Status: Update
• Public Device Record Key: 9f2ffded-7219-4a03-988c-9384d50da3df

Device Description

Pediatric-Infant Foam Sensor Wrap; For use with Product Codes OXI-P/I and D-YS.

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
KGX	Tape and bandage, adhesive	General Hospital	880.5240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34870	Basic electric hospital bed	A mains electricity (AC-powered) bed designed to be used as a patient bed for rest/sleep in a hospital ward/room, and which is motorized providing the patient/nursing staff with touch button adjustment possibilities. It typically includes a framework with wheels, a mattress support platform that can articulate, a headboard and footboard, siderails, and a remote control to operate the electrical motors. It may have an integrated weighing scale.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884522042816	GS1	PACK_OR_INNER_PACK	2	In Commercial Distribution
Primary	10884522042819	GS1
Package	40884522042810	GS1	CASE	50	In Commercial Distribution
Unit of Use	50884522042817	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Patient Weight, 3 to 40, KG;