Biotronix Healthcare RE-343002S

GUDID 10850005165092

Nebulizer with Adult Mask, 7ft. No Crush Tubing and Standard Connector

BIOTRONIX HEALTHCARE INDUSTRIES, INC.

Nebulizing system delivery set, single-use
Primary Device ID10850005165092
NIH Device Record Key5bea9911-3b14-451c-bee9-f53db7f0029c
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiotronix Healthcare
Version Model NumberRE-343002S
Catalog NumberRE-343002S
Company DUNS065762392
Company NameBIOTRONIX HEALTHCARE INDUSTRIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Countertrue

Customer Support Contacts

Phone786-473-9436
Emailmborges@biotronixhealthcare.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850005165095 [Primary]
GS110850005165092 [Package]
Contains: 00850005165095
Package: Case [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAFNebulizer (Direct Patient Interface)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-12-24
Device Publish Date2019-10-05

On-Brand Devices [Biotronix Healthcare]

20858835007053Disposable Hypodermic Needles 23G x 1"
20858835007046Disposable Hypodermic Needles 22G x 1 1/2"
20858835007039Disposable Hypodermic Needle 21G x 1 1/2
20858835007022Disposable Hypodermic Needle 20G x 1 1/2"
20858835007015Disposable Hypodermic Needle 18G x 1 1/2"
20858835007008Disposable Hypodermic Needles 18G x 1"
10850005165283Enteral Delivery Gravity Bag Set w/ ENFit™* Connector
10850005165276Enteral Delivery Pump Bag Set w/ ENFit™* Connector
10850005165108Nebulizer with Pediatric Elongated Mask, 7ft. No Crush Tubing and Standard Connector
10850005165092Nebulizer with Adult Mask, 7ft. No Crush Tubing and Standard Connector
10850005165078Nebulizer with Elongated Adult Mask, 7ft. No Crush Tubing and Universal Connector
10850005165054Minor Laceration Tray w/ Instrument
10850005165047Irrigation Tray with Piston Syringe
10850005165030Irrigation Tray with Bulb Syringe

Trademark Results [Biotronix Healthcare]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BIOTRONIX HEALTHCARE
BIOTRONIX HEALTHCARE
86094840 4616297 Live/Registered
Biotronix Healthcare Industries Inc.
2013-10-18

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