ProCare IR Thermometer

GUDID 00372217003014

ProCare IR Thermometer - EFT 161

ARISE MEDICAL LLC

Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear Infrared patient thermometer, ear

• Primary Device ID: 00372217003014
• NIH Device Record Key: 663fe8bd-2943-4331-a290-85361804b80b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProCare IR Thermometer
• Version Model Number: 240390
• Company DUNS: 081149273
• Company Name: ARISE MEDICAL 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: true
• 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	00372217003014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171214

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

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: 2018-11-01
• Device Publish Date: 2018-10-01

Devices Manufactured by ARISE MEDICAL LLC

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• 00372217036098 - Safecare Vinyl Exam Gloves: 2023-02-16 Safecare Vinyl Exam Gloves - L- 100 Ct
• 00372217036104 - Safecare Vinyl Exam Gloves: 2023-02-16 Safecare Vinyl Exam Gloves - XL- 100 Ct
• 00372217036319 - Safecare Vinyl Exam Gloves: 2023-02-16 Safecare Vinyl Exam Gloves - XS- 100 Ct
• 00372217036326 - Safecare Vinyl Exam Gloves: 2023-02-16 Safecare Vinyl Exam Gloves - S- 100 Ct
• 00372217004035 - Procare Basic Upper Arm BP Monitor: 2020-08-31 Upparm Arm blood pressure monitor with standard cuff
• 00372217004042 - Procare Upper Arm BP Monitor with XL Cuff: 2020-08-31 Procare Upper Arm BP Monitor with XL Cuff
• 00372217005094 - Safari Express Pediatric Nebulizer: 2020-08-31 Safari Express Pediatric Nebulizer