Biotronis Healthcare RE-343004U

GUDID 10850005165085

Nebulizer with Pediatric Elongated Mask, 7ft. No Crush Tubing and Universal Connector

BIOTRONIX HEALTHCARE INDUSTRIES, INC.

Nebulizing system delivery set, single-use

• Primary Device ID: 10850005165085
• NIH Device Record Key: d76ae232-b34a-4196-bed5-85d10a8fff9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biotronis Healthcare
• Version Model Number: RE-343004U
• Catalog Number: RE-343004U
• 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 Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005165088 [Primary]
GS1	10850005165085 [Package]; Contains: 00850005165088; 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

Devices Manufactured by BIOTRONIX HEALTHCARE INDUSTRIES, INC.

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• 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