MasimoSET® Replacement Wraps for LNOP® NeoPt Sensors

Basic Information

• Brand Name: MasimoSET® Replacement Wraps for LNOP® NeoPt Sensors
• Primary DI: 10843997000243
• Version / Model: 1053
• Catalog Number: 1053
• Company Name: MASIMO CORPORATION
• Labeler DUNS: 780421038
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2016-08-19
• Public Version: 7
• Public Version Date: 2022-11-17
• Public Version Status: Update
• Public Device Record Key: 19c6c1bb-f80f-42d2-aa4e-812098bb85c1

Device Description

MasimoSET Replacement Wraps for LNOP NeoPt Sensors

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: No
• 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
DQA	Oximeter	Cardiovascular	870.2700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16866	Dressing-fixation skin adhesive tape, non-silicone	A long and narrow flexible band of non-silicone-based material (e.g., fabric, plastic, paper) coated on one or both sides with a pressure-sensitive adhesive, intended to non-invasively adhere to the skin surface to fix a dressing in place or attach objects (e.g., catheter, lamp); it might have hypoallergenic and/or waterproof properties. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10843997000243	GS1
Unit of Use	00843997000246	GS1

Customer Contacts

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