CLINICAL HEALTH SERVICES, INC. CLIC503X-Clear

GUDID 00815290014992

Ultrasound Gel, CLEAR, 5Liter with Dispenser

CLINICAL HEALTH SERVICES, INC.

Coupling gel, non-sterile Coupling gel, non-sterile 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: 00815290014992
• NIH Device Record Key: d96f4077-b1f6-492f-a277-22ee0934299a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLINICAL HEALTH SERVICES, INC.
• Version Model Number: CLIC503X-Clear
• Catalog Number: CLIC503X-Clear
• Company DUNS: 004416769
• Company Name: CLINICAL HEALTH SERVICES, 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: 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: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 813-871-3120
• Email: jeff@clinicalhealthservices.com
• Phone: 813-871-3120
• Email: jeff@clinicalhealthservices.com
• Phone: 813-871-3120
• Email: jeff@clinicalhealthservices.com
• Phone: 813-871-3120
• Email: jeff@clinicalhealthservices.com
• Phone: 813-871-3120
• Email: jeff@clinicalhealthservices.com
• Phone: 813-871-3120
• Email: jeff@clinicalhealthservices.com
• Phone: 813-871-3120
• Email: jeff@clinicalhealthservices.com
• Phone: 813-871-3120
• Email: jeff@clinicalhealthservices.com
• Phone: 813-871-3120
• Email: jeff@clinicalhealthservices.com
• Phone: 813-871-3120
• Email: jeff@clinicalhealthservices.com
• Phone: 813-871-3120
• Email: jeff@clinicalhealthservices.com
• Phone: 813-871-3120
• Email: jeff@clinicalhealthservices.com
• Phone: 813-871-3120
• Email: jeff@clinicalhealthservices.com
• Phone: 813-871-3120
• Email: jeff@clinicalhealthservices.com
• Phone: 813-871-3120
• Email: jeff@clinicalhealthservices.com
• Phone: 813-871-3120
• Email: jeff@clinicalhealthservices.com
• Phone: 813-871-3120
• Email: jeff@clinicalhealthservices.com
• Phone: 813-871-3120
• Email: jeff@clinicalhealthservices.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815290013896 [Primary]
GS1	00815290014985 [Package]; Contains: 00815290013896; Package: Inner Pack [1 Units]; In Commercial Distribution
GS1	00815290014992 [Package]; Contains: 00815290014985; Package: Case [4 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: 2016-12-07

On-Brand Devices [CLINICAL HEALTH SERVICES, INC.]

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• 00815290015944: CHS220RWF- 2" round electrodes, white foam, carbon, plastic zip lock
• 00815290015913: CHS230TC- 2"x3.5" electrodes, tan cloth, carbon, plastic zip lock
• 00815290015869: CHS230WF- 2"x3.5" electrodes, white foam, carbon, plastic zip lock
• 00815290015524: CHS220WF- 2"x2" electrodes, white foam, carbon, plastic zip lock
• 00815290015517: CHS220WC- 2"x2" electrodes, white cloth, carbon, plastic zip lock
• 00815290015463: CHS220TC- 2"x2" electrodes, tan cloth, carbon, plastic zip lock
• 00815290015432: CHS220RTC 2" Round- 2" Round electrodes, tan cloth, carbon, plastic zip lock
• 00815290015364: CHS215TC- 1.5"x1.5" electrodes, tan cloth, carbon, plastic zip lock
• 00815290014992: Ultrasound Gel, CLEAR, 5Liter with Dispenser
• 00815290015005: Ultrasound Gel, BLUE, 5Liter with Dispenser
• 00815290013872: Ultrasound Lotion, Gallon with Dispenser
• 00815290016743: TC5050-WC- 2"x2" electrodes, white cloth, carbon, plastic zip lock
• 10815290016719: TC5050-TC- 2"x2" electrodes, tan cloth, carbon, plastic zip lock
• 00815290017641: TC5050-WF- 2"x2" electrodes, white foam, carbon, plastic zip lock
• 10815290018287: TC50100-TC- 2"x4" electrodes, tan cloth, carbon, plastic zip lock
• 00815290018266: TC50100-WF- 2"x4" electrodes, white foam, carbon, plastic zip lock
• 10815290018881: TC120R-WC, 2" Round electrodes, white cloth, carbon, plastic zip lock
• 10815290019161: R95D 3.75" Round, 3.75 Round Electrode, Standard Pin