AccuGel AG-08

GUDID 20851491007368

ACCUGEL ULTRASOUND GEL .025 LITER DISPENSER

Lynn Medical Instrument Co.

Coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Topical coupling gel, non-sterile Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel

• 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