| Primary Device ID | 20858835007923 |
| NIH Device Record Key | f74d3938-8cc8-41e0-9377-931144e4a182 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Biotronix Healthcare IV Catheters |
| Version Model Number | GEP050020-A |
| 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 | 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 | 786-473-9436 |
| mborges@biotronixhealthcare.com |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858835007929 [Primary] |
| GS1 | 10858835007926 [Package] Contains: 00858835007929 Package: inner box [50 Units] In Commercial Distribution |
| GS1 | 20858835007923 [Package] Contains: 10858835007926 Package: Case [40 Units] In Commercial Distribution |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days |
| 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 | 2019-10-03 |
| 20858835007947 | IV CATHETER 22G X 1 1/4" BLUE, |
| 20858835007930 | IV CATHETER 22G X 1" Blue |
| 20858835007923 | IV CATHETER 20G X 1 1/4" PINK, |
| 10858835007919 | Disposable I.V. Catheter 18G x 1.25" Green |
| 20858835007060 | Disposable I.V. Catheter 24G x 3/4",Yellow |