Procare Forehead Infrared Thermometer PG-IRT1602

GUDID 00372217003021

ARISE MEDICAL LLC

Infrared patient thermometer, skin

• Primary Device ID: 00372217003021
• NIH Device Record Key: 2ee8ab26-bc02-4262-8e09-644a330714c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procare Forehead Infrared Thermometer
• Version Model Number: 240540
• Catalog Number: PG-IRT1602
• 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00372217003021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182597

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: 2020-07-21
• Device Publish Date: 2020-07-13

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• 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
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• 00372217004042 - Procare Upper Arm BP Monitor with XL Cuff: 2020-08-31 Procare Upper Arm BP Monitor with XL Cuff
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