HoMedics PX-132-HP

GUDID 00031262099280

Pulse Oximeter

HOMEDICS USA, LLC

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• Primary Device ID: 00031262099280
• NIH Device Record Key: 2069cf65-ae7a-4d2e-8c6d-d20c8ef1a532
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HoMedics
• Version Model Number: PX-132-HP
• Catalog Number: PX-132-HP
• Company DUNS: 164414364
• Company Name: HOMEDICS USA, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com
• Phone: 1-800-466-3342
• Email: cservice@homedics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00031262099280 [Primary]
GS1	10031262099287 [Package]; Package: Case [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141105

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: 2020-07-13
• Device Publish Date: 2020-07-03

On-Brand Devices [HoMedics]

• 00031262099280: Pulse Oximeter
• 10031262101249: Infrared Ear/Forehead Thermometer
• 10031262101737: PILLOW WITH REMOVEABLE GEL