Aquaflex 04-90-820311

GUDID 10303410000026

Profound 3cm wide gel pad

PARKER LABORATORIES INC

Skin topical coupling gel

• Primary Device ID: 10303410000026
• NIH Device Record Key: f6ca3605-380d-46f3-92b2-b6fe8c79f49f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aquaflex
• Version Model Number: ULTRASOUND GEL PAD
• Catalog Number: 04-90-820311
• 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: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00303410000029 [Primary]
GS1	10303410000026 [Package]; Contains: 00303410000029; Package: Box [1 Units]; In Commercial Distribution
GS1	20303410000023 [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: 2024-09-05
• Device Publish Date: 2024-08-28

Devices Manufactured by PARKER LABORATORIES INC

• 10303410000026 - Aquaflex: 2024-09-05Profound 3cm wide gel pad
• 10303410000026 - Aquaflex: 2024-09-05 Profound 3cm wide gel pad
• 10855683006347 - ECLIPSE: 2024-06-05 Eclipse Probe Cover-latex free, 64 mm / 44 x 241 mm
• 10855683006354 - ECLIPSE: 2024-06-05 Eclipse Probe Cover, 83mm/43x241mm
• 10855683006361 - AQUAGEL: 2024-06-05 Aquagel Lubricating Gel, 5 oz. tube
• 20855683006542 - Ultradrape: 2023-09-26 Ultrasound Guided Peripheral Intravenous Barrier and Securement Device 3.25''x5.8''
• 20855683006917 - BrainScope: 2023-09-26 Skin Prep Gel 5g
• 00855683006920 - 1% KCl GEL: 2022-06-13 Bulk packed 1% KCl gel
• 00855683006883 - Alpha-Stim: 2022-03-09 Conducting solution