SureStep™ Foley Tray System Add-A-Foley Catheter A153200

GUDID 10801741121064

SureStep™ Foley Tray System Add-A-Foley Catheter

C. R. Bard, Inc.

Urethral catheterization support kit, urinary drainage Urethral catheterization support kit, urinary drainage Urethral catheterization support kit, urinary drainage Urethral catheterization support kit, urinary drainage Urethral catheterization support kit, urinary drainage Urethral catheterization support kit, urinary drainage Urethral catheterization support kit, urinary drainage Urethral catheterization support kit, urinary drainage Urethral catheterization support kit, urinary drainage Urethral catheterization support kit, urinary drainage Urethral catheterization support kit, urinary drainage Urethral catheterization support kit, urinary drainage Urethral catheterization support kit, urinary drainage Urethral catheterization support kit, urinary drainage Urethral catheterization support kit, urinary drainage Urethral catheterization support kit, urinary drainage

• Primary Device ID: 10801741121064
• NIH Device Record Key: fbca7370-e340-4c61-b8d8-5e4829757122
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureStep™ Foley Tray System Add-A-Foley Catheter
• Version Model Number: A153200
• Catalog Number: A153200
• Company DUNS: 016898496
• Company Name: C. R. Bard, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Labeled No Natural Rubber Latex: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00801741121067 [Primary]
GS1	10801741121064 [Package]; Contains: 00801741121067; Package: CA [10 Units]; In Commercial Distribution

FDA Product Code

• KNX: COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-04-09
• Device Publish Date: 2016-08-18

On-Brand Devices [SureStep™ Foley Tray System Add-A-Foley Catheter]

• 10801741121064: SureStep™ Foley Tray System Add-A-Foley Catheter
• 10801741100366: SureStep® Foley Tray System Add-A-Foley Catheter 2000 ml Drainage Bag
• 10801741100359: SureStep® Foley Tray System Add-A-Foley Catheter 350 ml Urine Meter