| Primary Device ID | B482Z201 |
| NIH Device Record Key | 09851938-5ba5-4ce8-b1ea-28893ae2d737 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Colonic Irrigation Kit |
| Version Model Number | Segmented Hose / Large Hydrokit |
| Catalog Number | Z-20 |
| Company DUNS | 562820084 |
| Company Name | TRANSCENDENCIAS COMERCIALES SL |
| 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 | false |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B482Z200 [Primary] |
| HIBCC | B482Z201 [Package] Contains: B482Z200 Package: Box [75 Units] In Commercial Distribution |
| HIBCC | B482Z202 [Package] Contains: B482Z200 Package: Box [100 Units] Discontinued: 2022-09-05 In Commercial Distribution |
| KPL | Colonic Irrigation System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-10-22 |
| Device Publish Date | 2016-12-29 |
| B482Z201 | Colon Hydrotherapy Disposable Single-Use Kit, consisting of a large size Bulb Style Speculum wit |
| B482Z171 | Colon Hydrotherapy Disposable Single-Use Kit, consisting of a large size Bulb Style Speculum wit |
| B482Z161 | Colon Hydrotherapy Disposable Single-Use Kit, consisting of a large size Bulb Style Speculum wit |
| B482Z101 | Colon Hydrotherapy Disposable Single-Use Kit, consisting of a small size Bulb Style Speculum wit |
| B482Z091 | Colon Hydrotherapy Disposable Single-Use Kit, consisting of a large size Bulb Style Speculum wit |