BabyDance

GUDID 00896593002480

Fertility lubricant, 40 gram tube with flip top cap, no applicators

FAIRHAVEN HEALTH, L.L.C.

Sexual lubricant

• Primary Device ID: 00896593002480
• NIH Device Record Key: 948a9905-69e9-496f-a3ba-15a1d9c15d22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BabyDance
• Version Model Number: 3
• Company DUNS: 063041611
• Company Name: FAIRHAVEN HEALTH, L.L.C.
• 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: 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: true

Customer Support Contacts

• Phone: (360)543-7888
• Email: suzanne@fairhavenhealth.com
• Phone: (360)543-7888
• Email: suzanne@fairhavenhealth.com
• Phone: (360)543-7888
• Email: suzanne@fairhavenhealth.com
• Phone: (360)543-7888
• Email: suzanne@fairhavenhealth.com
• Phone: (360)543-7888
• Email: suzanne@fairhavenhealth.com
• Phone: (360)543-7888
• Email: suzanne@fairhavenhealth.com
• Phone: (360)543-7888
• Email: suzanne@fairhavenhealth.com
• Phone: (360)543-7888
• Email: suzanne@fairhavenhealth.com
• Phone: (360)543-7888
• Email: suzanne@fairhavenhealth.com
• Phone: (360)543-7888
• Email: suzanne@fairhavenhealth.com
• Phone: (360)543-7888
• Email: suzanne@fairhavenhealth.com
• Phone: (360)543-7888
• Email: suzanne@fairhavenhealth.com
• Phone: (360)543-7888
• Email: suzanne@fairhavenhealth.com
• Phone: (360)543-7888
• Email: suzanne@fairhavenhealth.com
• Phone: (360)543-7888
• Email: suzanne@fairhavenhealth.com
• Phone: (360)543-7888
• Email: suzanne@fairhavenhealth.com
• Phone: (360)543-7888
• Email: suzanne@fairhavenhealth.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00896593002480 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162319

FDA Product Code

• PEB: Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible

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: 2020-05-15
• Device Publish Date: 2020-05-07

On-Brand Devices [BabyDance]

• 00896593002497: Fertility lubricant, 40 gram tube with 10 applicators
• 00896593002480: Fertility lubricant, 40 gram tube with flip top cap, no applicators
• 00896593002220: Fertility lubricant