Ultraphonic, 5 Liter w/ bottle

GUDID 00858703006269

Ultrasonic Gel

ACCELERATED CARE PLUS CORP

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 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 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: 00858703006269
• NIH Device Record Key: fe108ddb-7c38-4eed-910e-58c69009a1a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultraphonic, 5 Liter w/ bottle
• Version Model Number: 32060
• Company DUNS: 828331616
• Company Name: ACCELERATED CARE PLUS CORP
• 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: 800-350-1100
• Email: customersupport@acplus.com
• Phone: 800-350-1100
• Email: customersupport@acplus.com
• Phone: 800-350-1100
• Email: customersupport@acplus.com
• Phone: 800-350-1100
• Email: customersupport@acplus.com
• Phone: 800-350-1100
• Email: customersupport@acplus.com
• Phone: 800-350-1100
• Email: customersupport@acplus.com
• Phone: 800-350-1100
• Email: customersupport@acplus.com
• Phone: 800-350-1100
• Email: customersupport@acplus.com
• Phone: 800-350-1100
• Email: customersupport@acplus.com
• Phone: 800-350-1100
• Email: customersupport@acplus.com
• Phone: 800-350-1100
• Email: customersupport@acplus.com
• Phone: 800-350-1100
• Email: customersupport@acplus.com
• Phone: 800-350-1100
• Email: customersupport@acplus.com
• Phone: 800-350-1100
• Email: customersupport@acplus.com
• Phone: 800-350-1100
• Email: customersupport@acplus.com
• Phone: 800-350-1100
• Email: customersupport@acplus.com
• Phone: 800-350-1100
• Email: customersupport@acplus.com
• Phone: 800-350-1100
• Email: customersupport@acplus.com
• Phone: 800-350-1100
• Email: customersupport@acplus.com
• Phone: 800-350-1100
• Email: customersupport@acplus.com
• Phone: 800-350-1100
• Email: customersupport@acplus.com
• Phone: 800-350-1100
• Email: customersupport@acplus.com
• Phone: 800-350-1100
• Email: customersupport@acplus.com
• Phone: 800-350-1100
• Email: customersupport@acplus.com
• Phone: 800-350-1100
• Email: customersupport@acplus.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858703006269 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955246

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: 2016-09-06

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• 00858703006337 - Synchrony Dysphagia Solutions by ACP: 2023-09-11 Bioelectrical signal analysis software; Biomechanical function analysis, interactive rehabilitation system
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• 04041925002805 - OmniStand: 2023-09-11 Exerciser, non-measuring for stroke rehabilitation
• 00858703006139 - OmniVersa: 2023-08-25 Combination electrical stimulation/ultrasound for physical therapy