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 ID: 10850005165092
• NIH Device Record Key: 5bea9911-3b14-451c-bee9-f53db7f0029c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biotronix Healthcare
• Version Model Number: RE-343002S
• Catalog Number: RE-343002S
• 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: true

Customer Support Contacts

• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005165095 [Primary]
GS1	10850005165092 [Package]; Contains: 00850005165095; Package: Case [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140237

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-24
• Device Publish Date: 2019-10-05

On-Brand Devices [Biotronix Healthcare]

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