Tono-Pen AVIA®

GUDID 00812559010108

Handheld, battery-powered contact tonometer. Indications for use include measuring intraocular pressure (IOP) for suspected glaucoma, or when increased intraocular pressure is suspected.

REICHERT, INC.

Ophthalmic tonometer, battery-operated

• Primary Device ID: 00812559010108
• NIH Device Record Key: ab378887-d91a-4955-8025-62966a5b483f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tono-Pen AVIA®
• Version Model Number: 230650
• Company DUNS: 126650253
• Company Name: REICHERT, INC.
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-849-8955
• Email: reichert.information@ametek.com
• Phone: 1-888-849-8955
• Email: reichert.information@ametek.com
• Phone: 1-888-849-8955
• Email: reichert.information@ametek.com
• Phone: 1-888-849-8955
• Email: reichert.information@ametek.com
• Phone: 1-888-849-8955
• Email: reichert.information@ametek.com
• Phone: 1-888-849-8955
• Email: reichert.information@ametek.com
• Phone: 1-888-849-8955
• Email: reichert.information@ametek.com
• Phone: 1-888-849-8955
• Email: reichert.information@ametek.com
• Phone: 1-888-849-8955
• Email: reichert.information@ametek.com
• Phone: 1-888-849-8955
• Email: reichert.information@ametek.com
• Phone: 1-888-849-8955
• Email: reichert.information@ametek.com
• Phone: 1-888-849-8955
• Email: reichert.information@ametek.com
• Phone: 1-888-849-8955
• Email: reichert.information@ametek.com
• Phone: 1-888-849-8955
• Email: reichert.information@ametek.com
• Phone: 1-888-849-8955
• Email: reichert.information@ametek.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812559010108 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053430

FDA Product Code

• HKY: Tonometer, Manual

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

Devices Manufactured by REICHERT, INC.

• 00812559012485 - Ocu-Film® +": 2025-08-25
• 00812559012492 - Ocu-Film® +": 2025-08-22
• 00812559010238 - Ultramatic RX Master Phoropter: 2025-08-20
• 00812559010269 - Ultramatic RX Master Phoropter: 2025-08-20
• 00812559010290 - Illuminated Phoropter: 2025-08-20
• 00812559010320 - Illuminated Phoropter: 2025-08-20
• 00812559010559 - TF50 Trial Frame: 2025-08-20
• 00812559010566 - TS75 Trial Lens: 2025-08-20