AccuMed

GUDID 00854509005802

AccuMed AT2102 is a non-contact, battery operated infrared thermometer that measures body, room, and surface temperature through infrared heat waves.

AMCREST INDUSTRIES LLC

Infrared patient thermometer, skin

• Primary Device ID: 00854509005802
• NIH Device Record Key: 180bd9c7-057e-42c0-be4e-d1a09442255a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuMed
• Version Model Number: AC-AT2102
• Company DUNS: 064634625
• Company Name: AMCREST INDUSTRIES 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: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854509005802 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130231

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-09
• Device Publish Date: 2017-06-13

On-Brand Devices [AccuMed]

• 00859888005863: 10PK-ST-TENSPADS
• 00854509005802: AccuMed AT2102 is a non-contact, battery operated infrared thermometer that measures body, room,