BOEHRINGER® ViSiGi 3D® Calibration System size 36Fr Bypass/Short

GUDID 30816286020837

ViSiGi 3D® Calibration System size 36Fr Bypass/Short

BOEHRINGER LABORATORIES, LLC

Gastric calibration tube, non-sterile

• Primary Device ID: 30816286020837
• NIH Device Record Key: 92e5e843-55a6-4b86-b77a-0702612bfde1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BOEHRINGER® ViSiGi 3D® Calibration System size 36Fr Bypass/Short
• Version Model Number: 5236S
• Company DUNS: 079991657
• Company Name: BOEHRINGER LABORATORIES, LLC
• 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: false

Customer Support Contacts

• Phone: 610-278-0900
• Email: info@boehringerlabs.com
• Phone: 610-278-0900
• Email: info@boehringerlabs.com
• Phone: 610-278-0900
• Email: info@boehringerlabs.com
• Phone: 610-278-0900
• Email: info@boehringerlabs.com
• Phone: 610-278-0900
• Email: info@boehringerlabs.com
• Phone: 610-278-0900
• Email: info@boehringerlabs.com
• Phone: 610-278-0900
• Email: info@boehringerlabs.com
• Phone: 610-278-0900
• Email: info@boehringerlabs.com
• Phone: 610-278-0900
• Email: info@boehringerlabs.com
• Phone: 610-278-0900
• Email: info@boehringerlabs.com
• Phone: 610-278-0900
• Email: info@boehringerlabs.com
• Phone: 610-278-0900
• Email: info@boehringerlabs.com
• Phone: 610-278-0900
• Email: info@boehringerlabs.com
• Phone: 610-278-0900
• Email: info@boehringerlabs.com
• Phone: 610-278-0900
• Email: info@boehringerlabs.com
• Phone: 610-278-0900
• Email: info@boehringerlabs.com

Device Dimensions

• Catheter Gauge: 36 French
• Catheter Gauge: 36 French
• Catheter Gauge: 36 French
• Catheter Gauge: 36 French
• Catheter Gauge: 36 French
• Catheter Gauge: 36 French
• Catheter Gauge: 36 French
• Catheter Gauge: 36 French
• Catheter Gauge: 36 French
• Catheter Gauge: 36 French
• Catheter Gauge: 36 French
• Catheter Gauge: 36 French
• Catheter Gauge: 36 French
• Catheter Gauge: 36 French
• Catheter Gauge: 36 French
• Catheter Gauge: 36 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	10816286020833 [Primary]
GS1	30816286020837 [Package]; Contains: 10816286020833; Package: Box [5 Units]; In Commercial Distribution
GS1	50816286020831 [Package]; Contains: 10816286020833; Package: Carton [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130483

FDA Product Code

• KNT: Tubes, Gastrointestinal (And Accessories)

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: 2021-04-02
• Device Publish Date: 2018-07-01

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