PULSOX-300i

GUDID 00817770020646

Oximeter with Spot Check Probe

MAXTEC, LLC

Pulse oximeter, battery-powered Pulse oximeter, battery-powered Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter

Primary Device ID	00817770020646
NIH Device Record Key	87feccdb-d45f-4a14-8463-a9bfca7db035
Commercial Distribution Discontinuation	2019-05-06
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	PULSOX-300i
Version Model Number	R204P17-001
Company DUNS	169911828
Company Name	MAXTEC, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817770020646 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K053419

FDA Product Code

DQA

Oximeter

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	5
Public Version Date	2019-05-07
Device Publish Date	2016-09-27

On-Brand Devices [PULSOX-300i]

00817770021001	Oximeter Monitor
00817770020653	Oximeter with Soft Tip Probe
00817770020646	Oximeter with Spot Check Probe
00817770020639	Oximeter with Finger Probe
00817770020578	Oximeter Sleep Study with Soft Tip Probe and without Software
00817770020554	Oximeter Sleep Study with Soft Tip Probe
00817770020547	Oximeter Sleep Study without Software
00817770020530	Oximeter Sleep Study