The Babydust Method BDW1-S
GUDID 00869220000302
BABYDUST METHOD LLC, THE
Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid| Primary Device ID | 00869220000302 |
| NIH Device Record Key | a63e078e-3566-4fcb-908e-ae49a373e37c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | The Babydust Method |
| Version Model Number | BDW1-S |
| Catalog Number | BDW1-S |
| Company DUNS | 026887421 |
| Company Name | BABYDUST METHOD LLC, THE |
| 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 | true |
| 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 | true |
| OTC Over-The-Counter | true |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00869220000302 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K043443
FDA Product Code
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-04-20 |
On-Brand Devices [The Babydust Method]
| 00869220000302 | BDW1-S |
| 00869220000326 | BDW2-S |
Trademark Results [The Babydust Method]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 THE BABYDUST METHOD 87942541 not registered Live/Pending |
The Babydust Method LLC 2018-05-31 |
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