Primary Device ID | 07540198001135 |
NIH Device Record Key | d0489473-34e2-443c-9170-7bc124dcdb8c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Pro-Fit Eco-Flex |
Version Model Number | Small Kit with stop disc |
Catalog Number | 8117-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 | 07540198001111 [Primary] |
GS1 | 07540198001128 [Package] Contains: 07540198001111 Package: Dispensing Bag [10 Units] In Commercial Distribution |
GS1 | 07540198001135 [Package] Contains: 07540198001111 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 |