| Primary Device ID | 07540198001180 |
| NIH Device Record Key | ebca41cd-dcb8-4b72-af6c-097c8263a814 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pro-Fit Eco-Flex |
| Version Model Number | Regular Kit with guide rings |
| Catalog Number | 8143-EF |
| Company DUNS | 250896255 |
| Company Name | Prime Pacific Health Innovations Corporation |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07540198001166 [Primary] |
| GS1 | 07540198001173 [Package] Contains: 07540198001166 Package: Dispensing Bag [10 Units] In Commercial Distribution |
| GS1 | 07540198001180 [Package] Contains: 07540198001166 Package: Dispensing Bag [25 Units] In Commercial Distribution |
| FFQ | Speculum, Rectal |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-10-22 |
| Device Publish Date | 2016-09-23 |
| 07540198001296 | The Pro-Fit Eco-Flex Universal Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit co |
| 07540198001234 | The Pro-Fit Eco-Flex Small Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consis |
| 07540198001180 | The Pro-Fit Eco-Flex Regular Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit cons |
| 07540198001135 | The Pro-Fit Eco-Flex Small Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit consis |
| 07540198001081 | The Pro-Fit Eco-Flex Regular Kit is a Colon Hydrotherapy Disposable Single-Use Speculum Kit cons |