| Primary Device ID | 50732224004988 |
| NIH Device Record Key | 2ba9a435-7c1a-4277-ba6e-cae8a2f45759 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Safe-Flo Plus Saliva Ejector |
| Version Model Number | M1003CLWH |
| Catalog Number | M1003CLWH |
| Company DUNS | 057728685 |
| Company Name | CROSSTEX INTERNATIONAL, INC. |
| Device Count | 100 |
| DM Exempt | true |
| Pre-market Exempt | true |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +1(585)359-0130 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0130 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0130 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0130 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0130 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0130 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0130 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0130 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0130 |
| regulatoryaffairs@hu-friedy.com | |
| Phone | +1(585)359-0130 |
| regulatoryaffairs@hu-friedy.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00732224005003 [Unit of Use] |
| GS1 | 10732224005000 [Primary] |
| GS1 | 50732224004988 [Package] Contains: 10732224005000 Package: Case [20 Units] In Commercial Distribution |
| DYN | Mouthpiece, saliva ejector |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-02 |
| Device Publish Date | 2024-11-22 |
| 50732224005022 | White/Pink, Bubblegum Scented |
| 50732224005015 | White/Green, Mint Scented |
| 50732224004988 | Clear/White |
| 50732224005008 | White/White |