SportLube

GUDID 40865542000356

WESTRIDGE LABORATORIES INCORPORATED

Sexual lubricant

• Primary Device ID: 40865542000356
• NIH Device Record Key: 60edcd25-4f6b-420f-bc53-1c75c1788c8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SportLube
• Version Model Number: Sportlube 3.4 fl oz Water Based
• Company DUNS: 879057065
• Company Name: WESTRIDGE LABORATORIES INCORPORATED
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00865542000358 [Primary]
GS1	40865542000356 [Package]; Contains: 00865542000358; Package: Case [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051295

FDA Product Code

• NUC: Lubricant, Personal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-08-09
• Device Publish Date: 2018-03-06

On-Brand Devices [SportLube]

• 40865542000370: Sportlube 1 fl oz Water Based
• 40865542000363: SportLube 1 fl oz Bottle
• 40865542000356: Sportlube 3.4 fl oz Water Based
• 40865542000349: SportLube 3.4 fl oz Silicone Based
• 30865542000328: Sportlube 8.1 fl oz Water Based
• 00865542000303: Sport Lube 8.1 fl oz Silicone Bottle