SureStep™ Foley Tray System Bardex® I.C. Temperature Sensing Foley Catheter Tray A901216

GUDID 10801741121033

SureStep™ Foley Tray System Bardex® I.C. Temperature Sensing Foley Catheter Tray

C. R. Bard, Inc.

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• Primary Device ID: 10801741121033
• NIH Device Record Key: 26b01293-41dd-4e0d-a01f-5f1463c9da41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureStep™ Foley Tray System Bardex® I.C. Temperature Sensing Foley Catheter Tray
• Version Model Number: A901216
• Catalog Number: A901216
• Company DUNS: 016898496
• Company Name: C. R. Bard, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com

Device Dimensions

• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French
• Catheter Gauge: 16 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741121036 [Primary]
GS1	10801741121033 [Package]; Contains: 00801741121036; Package: CA [10 Units]; In Commercial Distribution

FDA Product Code

• MJC: CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES

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: 2018-03-29
• Device Publish Date: 2016-08-16

On-Brand Devices [SureStep™ Foley Tray System Bardex® I.C. Temperature Sensing Foley Catheter Tray]

• 10801741121057: SureStep™ Foley Tray System Bardex® I.C. Temperature Sensing Foley Catheter Tray
• 10801741121033: SureStep™ Foley Tray System Bardex® I.C. Temperature Sensing Foley Catheter Tray
• 10801741120968: SureStep™ Foley Tray System Bardex® I.C. Temperature Sensing Foley Catheter Tray
• 10801741120944: SureStep™ Foley Tray System Bardex® I.C. Temperature Sensing Foley Catheter Tray