Masimo Pulse Oximeter Probe

Basic Information

• Brand Name: Masimo Pulse Oximeter Probe
• Primary DI: 00816317020484
• Version / Model: RM-2319
• Company Name: RENU MEDICAL, INC
• Labeler DUNS: 100439103
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-05-17
• Public Version: 6
• Public Version Date: 2023-09-08
• Public Version Status: Update
• Public Device Record Key: 85c54f4c-c015-40eb-8144-51fbcf02e5e0

Device Description

LNCS Infant Probe-L

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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
NLF	Oximeter, Reprocessed	Cardiovascular	870.2700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36087	Pulse oximeter probe, reprocessed	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. This is a single-use device that has previously been used on a patient and has been subjected to additional processing and manufacturing for an additional single-use patient application.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10816317020481	GS1	Case	20	In Commercial Distribution
Primary	00816317020484	GS1

Premarket Submissions

Submission Number	Supplement Number
K081927	000