Primary Device ID | 20858835007794 |
NIH Device Record Key | 36b5cd2c-5e96-4356-9e74-106d9b46106d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Bio-Gaurd Safety Needles |
Version Model Number | BIO-1011S |
Catalog Number | BIO-1011S |
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 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00858835007790 [Primary] |
GS1 | 10858835007797 [Package] Contains: 00858835007790 Package: Inner Box [100 Units] In Commercial Distribution |
GS1 | 20858835007794 [Package] Contains: 10858835007797 Package: Case [8 Units] In Commercial Distribution |
FMI | Needle, Hypodermic, Single Lumen |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2019-12-24 |
Device Publish Date | 2019-10-10 |
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 | 2019-12-24 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 |