BabyDance
GUDID 00896593002220
Fertility lubricant
FAIRHAVEN HEALTH, L.L.C.
Sexual lubricant| Primary Device ID | 00896593002220 |
| NIH Device Record Key | bee3461d-9d7e-4950-b166-9da4d6d226ec |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BabyDance |
| Version Model Number | 1 |
| 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 |
| suzanne@fairhavenhealth.com | |
| Phone | (360)543-7888 |
| suzanne@fairhavenhealth.com | |
| Phone | (360)543-7888 |
| suzanne@fairhavenhealth.com | |
| Phone | (360)543-7888 |
| suzanne@fairhavenhealth.com | |
| Phone | (360)543-7888 |
| suzanne@fairhavenhealth.com | |
| Phone | (360)543-7888 |
| suzanne@fairhavenhealth.com | |
| Phone | (360)543-7888 |
| suzanne@fairhavenhealth.com | |
| Phone | (360)543-7888 |
| suzanne@fairhavenhealth.com | |
| Phone | (360)543-7888 |
| suzanne@fairhavenhealth.com | |
| Phone | (360)543-7888 |
| suzanne@fairhavenhealth.com | |
| Phone | (360)543-7888 |
| suzanne@fairhavenhealth.com | |
| Phone | (360)543-7888 |
| suzanne@fairhavenhealth.com | |
| Phone | (360)543-7888 |
| suzanne@fairhavenhealth.com | |
| Phone | (360)543-7888 |
| suzanne@fairhavenhealth.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00896593002220 [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 | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-08-07 |
| Device Publish Date | 2017-11-09 |
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 |
Trademark Results [BabyDance]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BABYDANCE 86189497 5418474 Live/Registered |
Fairhaven Health, LLC 2014-02-10 |
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