AQUAGEL 57-05-1

GUDID 30855683006365

AQUAGEL LUBRICATING GEL 5 OZ TUBE

PARKER LABORATORIES INC

Electrode conductive medium

• Primary Device ID: 30855683006365
• NIH Device Record Key: bff4db1f-c09f-4a51-907d-1dacafb6787b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AQUAGEL
• Version Model Number: LUBRICATING GEL
• Catalog Number: 57-05-1
• Company DUNS: 002449593
• Company Name: PARKER LABORATORIES INC
• Device Count: 100
• 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	00855683006364 [Unit of Use]
GS1	30855683006365 [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: 2017-07-05

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
• 10855683006361: Aquagel Lubricating Gel, 5 oz. tube