Primary Device ID | 20850005165310 |
NIH Device Record Key | 486c8260-31c5-4229-af47-af4b26be5d39 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Biotronix Healthcare Blunt Fill Needles with Filters |
Version Model Number | GEBF5006 |
Catalog Number | GEBF5006 |
Company DUNS | 065762392 |
Company Name | BIOTRONIX HEALTHCARE INDUSTRIES, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | 00850005165316 [Primary] |
GS1 | 10850005165313 [Package] Contains: 00850005165316 Package: Inner Box [100 Units] In Commercial Distribution |
GS1 | 20850005165310 [Package] Contains: 10850005165313 Package: Case [10 Units] In Commercial Distribution |
GAA | Needle, Aspiration And Injection, Disposable |
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 | 2019-10-12 |
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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 |
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10850005165047 - Biotronix Healthcare | 2019-12-24 Irrigation Tray with Piston Syringe |
10850005165054 - Biotronix Healthcare | 2019-12-24 Minor Laceration Tray w/ Instrument |