AQUAGEL 57-20

GUDID 00855683006371

AQUAGEL LUBRICATING GEL 1/2 GAL BOTTLE

PARKER LABORATORIES INC

Electrode conductive medium

• Primary Device ID: 00855683006371
• NIH Device Record Key: 80d1df7e-40f1-4174-9dda-b167e3bcb92d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AQUAGEL
• Version Model Number: LUBRICATING GEL
• Catalog Number: 57-20
• 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: false

Customer Support Contacts

• Phone: 1-973-276-9500
• Email: customersupport@parkerlabs.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855683006371 [Primary]
GS1	10855683006378 [Package]; Package: BOX [1 Units]; In Commercial Distribution
GS1	20855683006375 [Package]; Contains: 10855683006378; Package: BOX [4 Units]; In Commercial Distribution

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: 2016-12-19

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