| Primary Device ID | 10850005165023 |
| NIH Device Record Key | c5f760db-b451-4903-a7a7-7393b241ef78 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Biotronix Healthcare Enema Bag Set |
| Version Model Number | GE41001 |
| Catalog Number | GE41001 |
| Company DUNS | 065762392 |
| Company Name | BIOTRONIX HEALTHCARE INDUSTRIES, INC. |
| 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 | 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 | 786-473-9436 |
| mborges@biotronixhealthcare.com |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850005165026 [Primary] |
| GS1 | 10850005165023 [Package] Contains: 00850005165026 Package: Case [48 Units] In Commercial Distribution |
| FCE | Enema Kit |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-12-24 |
| Device Publish Date | 2019-10-04 |
| 10850005165573 - Biotroix Healthcare Syringes | 2024-03-19 Syringe 1cc Luer Lock without needle, Each |
| 10850005165290 - Biotronix Healthcare Suture Removal Tray | 2021-02-08 Suture Removal Tray |
| 10850005165009 - Biotronix Healthcare Foley Trays | 2019-12-24 Pre-Connected Latex Foley Tray 18FR |
| 10850005165016 - Biotronix Healthcare Urethral Catheter Trays | 2019-12-24 Intermittent Urethral Catheter Tray 14FR, PVC |
| 10850005165023 - Biotronix Healthcare Enema Bag Set | 2019-12-24Enema Bag Set |
| 10850005165023 - Biotronix Healthcare Enema Bag Set | 2019-12-24 Enema Bag Set |
| 10850005165030 - Biotronix Healthcare | 2019-12-24 Irrigation Tray with Bulb Syringe |
| 10850005165047 - Biotronix Healthcare | 2019-12-24 Irrigation Tray with Piston Syringe |
| 10850005165054 - Biotronix Healthcare | 2019-12-24 Minor Laceration Tray w/ Instrument |