Clik-FIX FCS-1074

GUDID 10850933007280

Foley Catheter Securement device for 10-14 Fr.

STARBOARD MEDICAL, INC.

Urinary catheter holder, sterile

• Primary Device ID: 10850933007280
• NIH Device Record Key: b262c1ae-c05a-4ff4-a86c-562d6323678a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clik-FIX
• Version Model Number: FCS-1074
• Catalog Number: FCS-1074
• Company DUNS: 012983893
• Company Name: STARBOARD MEDICAL, 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850933007283 [Primary]
GS1	10850933007280 [Package]; Contains: 00850933007283; Package: Box [50 Units]; In Commercial Distribution

FDA Product Code

• EYJ: Holder, Ureteral Catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-26
• Device Publish Date: 2019-04-18

On-Brand Devices [Clik-FIX]

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• 00850933007252: Click-FIX Luer Lock Securement, Pediatric
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• 10850933007211: Foley catheter securement device
• 10850933007198: All 'n One Winged Catheter Securement With Dressing Large
• 10850933007181: All 'n One Securement for Large Luer Lock or Block
• 00850933007160: Standalone Securement for Large Luer Lock or Block
• 00850933007153: Clik-FIX Luer Lock Securement
• 10850933007143: All 'n One PICC/Central Catheter Securement
• 10850933007136: Clik-FIX Catheter Securement for PICC and Central Catheters with wings. Foam pad.
• 10850933007013: Clik-FIX All 'n One Peripheral IV Securement
• 10850933007006: Clik-FIX Securement System for non-cut to length catheters secured with block.
• 10850933007297: Foley Catheter Securement device for 5-8 Fr.
• 10850933007280: Foley Catheter Securement device for 10-14 Fr.
• 10850933007273: Foley drainage tube securement device
• 00850933007269: Neonatal PICC Securement Device with hook and loop
• 10850933007242: IV Start Kit with Clik-FIX All 'n One Peripheral IV Securement
• 20850933007201: IV Start Kit with Clik-FIX Universal Hub Securement