AccuGel AG-08

GUDID 20851491007368

ACCUGEL ULTRASOUND GEL .025 LITER DISPENSER

Lynn Medical Instrument Co.

Coupling gel, non-sterile

• Primary Device ID: 20851491007368
• NIH Device Record Key: ec493459-fe0a-40c6-87da-51479e7f96ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuGel
• Version Model Number: AG-08
• Catalog Number: AG-08
• Company DUNS: 058810771
• Company Name: Lynn Medical Instrument Co.
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1888-596-6633
• Email: customerservice@lynnmed.com
• Phone: 1888-596-6633
• Email: customerservice@lynnmed.com
• Phone: 1888-596-6633
• Email: customerservice@lynnmed.com
• Phone: 1888-596-6633
• Email: customerservice@lynnmed.com
• Phone: 1888-596-6633
• Email: customerservice@lynnmed.com
• Phone: 1888-596-6633
• Email: customerservice@lynnmed.com
• Phone: 1888-596-6633
• Email: customerservice@lynnmed.com
• Phone: 1888-596-6633
• Email: customerservice@lynnmed.com
• Phone: 1888-596-6633
• Email: customerservice@lynnmed.com
• Phone: 1888-596-6633
• Email: customerservice@lynnmed.com
• Phone: 1888-596-6633
• Email: customerservice@lynnmed.com
• Phone: 1888-596-6633
• Email: customerservice@lynnmed.com
• Phone: 1888-596-6633
• Email: customerservice@lynnmed.com
• Phone: 1888-596-6633
• Email: customerservice@lynnmed.com
• Phone: 1888-596-6633
• Email: customerservice@lynnmed.com
• Phone: 1888-596-6633
• Email: customerservice@lynnmed.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851491007364 [Primary]
GS1	10851491007361 [Package]; Contains: 00851491007364; Package: BX [12 Units]; In Commercial Distribution
GS1	20851491007368 [Package]; Contains: 00851491007364; Package: CS [48 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012522

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

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: 2017-02-13

On-Brand Devices [AccuGel]

• 20851491007368: ACCUGEL ULTRASOUND GEL .025 LITER DISPENSER
• 00851491007340: ACCUGEL ULTRASOUND 5 LITER BOTTLE
• 10851491007330: ACCUGEL ULTRASOUND 5 LITER CLEAR GEL HIGH VISCOSITY