Biotronix Healthcare Foley Trays

GUDID 10850005165009

Pre-Connected Latex Foley Tray 18FR

BIOTRONIX HEALTHCARE INDUSTRIES, INC.

Indwelling urethral catheterization kit

• Primary Device ID: 10850005165009
• NIH Device Record Key: e15d17a9-5abe-462d-8859-c9eae1403f14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biotronix Healthcare Foley Trays
• Version Model Number: UR1428FT
• 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: true
• 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

Customer Support Contacts

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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005165002 [Primary]
GS1	10850005165009 [Package]; Contains: 00850005165002; Package: Case [10 Units]; In Commercial Distribution

FDA Product Code

• OHR: Catheter Care Tray

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-24
• Device Publish Date: 2019-10-04

On-Brand Devices [Biotronix Healthcare Foley Trays]

• 10864085000495: Pre-Connected Latex Foley Tray 16FR
• 10850005165009: Pre-Connected Latex Foley Tray 18FR