AQUAGEL 57-01-5

GUDID 20855683006474

AQUAGEL LUBRICATING GEL 20 g packette

PARKER LABORATORIES INC

Electrode conductive medium Electrode conductive medium

• Primary Device ID: 20855683006474
• NIH Device Record Key: b53e119d-50db-4506-b653-efc2ddbda0eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AQUAGEL
• Version Model Number: LUBRICATING GEL
• Catalog Number: 57-01-5
• Company DUNS: 002449593
• Company Name: PARKER LABORATORIES INC
• Device Count: 500
• 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: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855683006470 [Unit of Use]
GS1	20855683006474 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K864556

FDA Product Code

• KMJ: Lubricant, Patient

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-22
• Device Publish Date: 2016-12-06

On-Brand Devices [AQUAGEL]

• 00855683006371: AQUAGEL LUBRICATING GEL 1/2 GAL BOTTLE
• 30855683006365: AQUAGEL LUBRICATING GEL 5 OZ TUBE
• 20855683006474: AQUAGEL LUBRICATING GEL 20 g packette