Primary Device ID | 20858835007312 |
NIH Device Record Key | 762aacba-996d-4455-b6da-10dc28e2bef6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Biotronix Healthcare Syringes |
Version Model Number | GE12023 |
Catalog Number | GE12023 |
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 |
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Device Issuing Agency | Device ID |
---|---|
GS1 | 00858835007318 [Primary] |
GS1 | 10858835007315 [Package] Contains: 00858835007318 Package: Inner Box [100 Units] In Commercial Distribution |
GS1 | 20858835007312 [Package] Contains: 10858835007315 Package: Case [8 Units] In Commercial Distribution |
FMF | Syringe, Piston |
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 | 2019-10-12 |
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 |