Aquaflex 04-95-820311

GUDID 10303410000033

Profound 3cm narrow gel pad

PARKER LABORATORIES INC

Skin topical coupling gel

• Primary Device ID: 10303410000033
• NIH Device Record Key: c0074a91-af0f-4950-b485-e0d00303313a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aquaflex
• Version Model Number: ULTRASOUND GEL PAD
• Catalog Number: 04-95-820311
• Company DUNS: 002449593
• Company Name: PARKER LABORATORIES 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: true

Customer Support Contacts

• Phone: 973-276-9500
• Email: customerservice@parkerlabs.com
• Phone: 973-276-9500
• Email: customerservice@parkerlabs.com
• Phone: 973-276-9500
• Email: customerservice@parkerlabs.com
• Phone: 973-276-9500
• Email: customerservice@parkerlabs.com
• Phone: 973-276-9500
• Email: customerservice@parkerlabs.com
• Phone: 973-276-9500
• Email: customerservice@parkerlabs.com
• Phone: 973-276-9500
• Email: customerservice@parkerlabs.com
• Phone: 973-276-9500
• Email: customerservice@parkerlabs.com
• Phone: 973-276-9500
• Email: customerservice@parkerlabs.com
• Phone: 973-276-9500
• Email: customerservice@parkerlabs.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00303410000036 [Primary]
GS1	10303410000033 [Package]; Contains: 00303410000036; Package: Box [1 Units]; In Commercial Distribution
GS1	20303410000030 [Package]; Package: Box [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K851895

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-28
• Device Publish Date: 2024-11-20

On-Brand Devices [Aquaflex]

• 10303410000026: Profound 3cm wide gel pad
• 10303410000033: Profound 3cm narrow gel pad
• 10303410000019: Profound 2cm wide gel pad