PALMSAT HANDHELD OXIMETER

GUDID 00833166000122

PALMSAT HANDHELD OXIMETER WITH 8000SM SENSOR

NONIN MEDICAL, INC.

Pulse oximeter

• Primary Device ID: 00833166000122
• NIH Device Record Key: 7e51bad9-eac7-46ae-8b35-5c1136e92ca3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PALMSAT HANDHELD OXIMETER
• Version Model Number: 2500,8000SM
• Company DUNS: 174959692
• Company Name: NONIN MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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	00833166000122 [Primary]

FDA Product Code

• DQA: Oximeter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-18
• Device Publish Date: 2024-09-10

On-Brand Devices [PALMSAT HANDHELD OXIMETER]

• 00833166000054: PALMSAT HANDHELD OXIMETER with 8001J sensor
• 00833166000146: PALMSAT HANDHELD OXIMETER with 8000SL sensor
• 00833166000139: PALMSAT HANDHELD OXIMETER with 8000SM-3
• 00833166000122: PALMSAT HANDHELD OXIMETER WITH 8000SM SENSOR