| Primary Device ID | 10868538000414 |
| NIH Device Record Key | 515c8cb9-faaf-49e6-8c03-dc57ddedaf24 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LIBBE Colonic Nozzle |
| Version Model Number | 298-8888 |
| Company DUNS | 929869659 |
| Company Name | Mind Body Naturopathic Inst |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | (210) 308-8888 |
| qc@colonic.net | |
| Phone | (210) 308-8888 |
| qc@colonic.net | |
| Phone | (210) 308-8888 |
| qc@colonic.net | |
| Phone | (210) 308-8888 |
| qc@colonic.net | |
| Phone | (210) 308-8888 |
| qc@colonic.net | |
| Phone | (210) 308-8888 |
| qc@colonic.net | |
| Phone | (210) 308-8888 |
| qc@colonic.net | |
| Phone | (210) 308-8888 |
| qc@colonic.net | |
| Phone | (210) 308-8888 |
| qc@colonic.net | |
| Phone | (210) 308-8888 |
| qc@colonic.net | |
| Phone | (210) 308-8888 |
| qc@colonic.net | |
| Phone | (210) 308-8888 |
| qc@colonic.net | |
| Phone | (210) 308-8888 |
| qc@colonic.net | |
| Phone | (210) 308-8888 |
| qc@colonic.net | |
| Phone | (210) 308-8888 |
| qc@colonic.net |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00868538000417 [Primary] |
| GS1 | 10868538000414 [Package] Contains: 00868538000417 Package: Box [50 Units] In Commercial Distribution |
| KPL | Colonic Irrigation System |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-10 |
| Device Publish Date | 2021-04-30 |
| 10868538000414 - LIBBE Colonic Nozzle | 2021-05-10One-piece, smooth body, molded, tube shaped, medical grade plastic accessory that is for colon cleansing when medically indicated, such as before radiological or endoscopic examination. |
| 10868538000414 - LIBBE Colonic Nozzle | 2021-05-10 One-piece, smooth body, molded, tube shaped, medical grade plastic accessory that is for colon cleansing when medically indicate |
| 00868538000400 - LIBBE Colon Hydrotherapy System | 2018-07-06 The LIBBE System is designed to allow evacuation of the contents of the colon during the administration of the colonic irrigatio |