Dover 8887630260

GUDID 20192253024194

100% SILICONE FOLEY CATHETER, 30 CC, 2-WAY, 26 FR (8.7 MM)

Cardinal Health 200, LLC

Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial

• Primary Device ID: 20192253024194
• NIH Device Record Key: fbc48492-954f-4790-8b3d-a88cc66e46d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dover
• Version Model Number: 8887630260
• Catalog Number: 8887630260
• Company DUNS: 961027315
• Company Name: Cardinal Health 200, 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Catheter Gauge: 26 French
• Catheter Gauge: 26 French
• Catheter Gauge: 26 French
• Catheter Gauge: 26 French
• Catheter Gauge: 26 French
• Catheter Gauge: 26 French
• Catheter Gauge: 26 French
• Catheter Gauge: 26 French
• Catheter Gauge: 26 French
• Catheter Gauge: 26 French
• Catheter Gauge: 26 French
• Catheter Gauge: 26 French
• Catheter Gauge: 26 French
• Catheter Gauge: 26 French
• Catheter Gauge: 26 French
• Catheter Gauge: 26 French
• Catheter Gauge: 26 French
• Catheter Gauge: 26 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	10192253024197 [Primary]
GS1	20192253024194 [Package]; Contains: 10192253024197; Package: Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K833790

FDA Product Code

• EZL: CATHETER, RETENTION TYPE, BALLOON
• KOD: CATHETER, UROLOGICAL

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: 2022-07-14
• Device Publish Date: 2022-07-06

On-Brand Devices [Dover]

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• 50192253024171: 100% SILICONE FOLEY CATHETER, COUNCIL TIP, 5 CC, 2-WAY, 24 FR (8.0 MM)
• 50192253024164: 100% SILICONE FOLEY CATHETER, COUNCIL TIP, 5 CC, 2-WAY, 22 FR (7.3 MM)
• 50192253024157: 100% SILICONE FOLEY CATHETER, COUNCIL TIP, 5 CC, 2-WAY, 20 FR (6.7 MM)
• 20192253024149: 100% SILICONE FOLEY CATHETER, COUNCIL TIP, 5 CC, 2-WAY, 18 FR (6.0 MM)
• 20192253024132: 100% SILICONE FOLEY CATHETER, COUNCIL TIP, 5 CC, 2-WAY, 16 FR (5.3 MM)
• 20192253024125: 100% SILICONE FOLEY CATHETER, 30 CC, 3-WAY, 28 FR (9.3 MM)
• 50192253024102: 100% SILICONE FOLEY CATHETER, 30 CC, 3-WAY, 26 FR (8.7 MM)
• 50192253024096: 100% SILICONE FOLEY CATHETER, 30 CC, 3-WAY, 16 FR (5.3 MM)
• 50192253024089: 100% SILICONE FOLEY CATHETER, 5 CC, 3-WAY 28 FR (9.3 MM)
• 50192253024072: 100% SILICONE FOLEY CATHETER, 5 CC, 3-WAY 26 FR (8.7 MM)
• 20192253024064: 100% SILICONE FOLEY CATHETER, 5 CC, 3-WAY 24 FR (8.0 MM)
• 20192253024057: 100% SILICONE FOLEY CATHETER, 5 CC, 3-WAY 22 FR (7.3 MM)
• 20192253024040: 100% SILICONE FOLEY CATHETER, 5 CC, 3-WAY 20 FR (6.7 MM)
• 50192253024034: 100% SILICONE FOLEY CATHETER, 5 CC, 3-WAY 18 FR (6.0 MM)
• 50192253024027: 100% SILICONE FOLEY CATHETER, 5 CC, 3-WAY 16 FR (5.3 MM)
• 50192253024010: 100% SILICONE FOLEY CATHETER, 30 CC, 2-WAY, 30 FR (10.0 MM)
• 20192253024002: 100% SILICONE FOLEY CATHETER, 30 CC, 2-WAY, 28 FR (9.3 MM)
• 50192253023990: 100% SILICONE FOLEY CATHETER, 30 CC, 2-WAY, 16 FR (5.3 MM)
• 20192253023982: 100% SILICONE FOLEY CATHETER, 30 CC, 2-WAY, 14 FR (4.7 MM)
• 50192253023976: 100% SILICONE FOLEY CATHETER, 5 CC, 2-WAY, 30 FR (10.0 MM)
• 50192253023969: 100% SILICONE FOLEY CATHETER, 5 CC, 2-WAY, 28 FR (9.3 MM)
• 20192253029427: HYDROPHILIC COATED RED RUBBER URETHRAL CATHETER, SMOOTH ROUNDED TIP, 18 FR (6.0 MM)
• 20192253026594: HYDROPHILIC COATED RED RUBBER URETHRAL CATHETER, SMOOTH ROUNDED TIP, 24 FR (8.0 MM)
• 20192253026587: HYDROPHILIC COATED RED RUBBER URETHRAL CATHETER, SMOOTH ROUNDED TIP, 22 FR (7.3 MM)
• 20192253026570: HYDROPHILIC COATED RED RUBBER URETHRAL CATHETER, SMOOTH ROUNDED TIP, 20 FR (6.7 MM)
• 20192253026563: HYDROPHILIC COATED RED RUBBER URETHRAL CATHETER, SMOOTH ROUNDED TIP, 16 FR (5.3 MM)
• 20192253026556: HYDROPHILIC COATED RED RUBBER URETHRAL CATHETER, SMOOTH ROUNDED TIP, 14 FR (4.7 MM)
• 50192253026540: HYDROPHILIC COATED RED RUBBER URETHRAL CATHETER, SMOOTH ROUNDED TIP, 12 FR (4.0 MM)
• 50192253026533: HYDROPHILIC COATED RED RUBBER URETHRAL CATHETER, SMOOTH ROUNDED TIP, 10 FR (3.3 MM)
• 20192253026525: HYDROPHILIC COATED RED RUBBER URETHRAL CATHETER, SMOOTH ROUNDED TIP, 8 FR (2.7 MM)
• 20192253027607: SILICONE OIL COATED LATEX FOLEY CATHETER 30 CC, 2-WAY, 14 FR (4.7 MM)
• 20192253026495: SILICONE OIL COATED LATEX FOLEY CATHETER 30 CC, 2-WAY, 30 FR (10.0 MM)
• 20192253026488: SILICONE OIL COATED LATEX FOLEY CATHETER 30 CC, 2-WAY, 28 FR (9.3 MM)
• 20192253026471: SILICONE OIL COATED LATEX FOLEY CATHETER 30 CC, 2-WAY, 26 FR (8.7 MM)
• 20192253026464: SILICONE OIL COATED LATEX FOLEY CATHETER 30 CC, 2-WAY, 24 FR (8.0 MM)
• 20192253026457: SILICONE OIL COATED LATEX FOLEY CATHETER 30 CC, 2-WAY, 22 FR (7.3 MM)
• 20192253026440: SILICONE OIL COATED LATEX FOLEY CATHETER 30 CC, 2-WAY, 20 FR (6.7 MM)
• 20192253026433: SILICONE OIL COATED LATEX FOLEY CATHETER 30 CC, 2-WAY, 18 FR (6.0 MM)
• 20192253026426: SILICONE OIL COATED LATEX FOLEY CATHETER 30 CC, 2-WAY, 16 FR (5.3 MM)
• 20192253026419: SILICONE OIL COATED LATEX FOLEY CATHETER 5 CC, 2-WAY, 30 FR (10.0 MM)
• 20192253026402: SILICONE OIL COATED LATEX FOLEY CATHETER 5 CC, 2-WAY, 28 FR (9.3 MM)
• 20192253026396: SILICONE OIL COATED LATEX FOLEY CATHETER 5 CC, 2-WAY, 26 FR (8.7 MM)
• 20192253026389: SILICONE OIL COATED LATEX FOLEY CATHETER 5 CC, 2-WAY, 24 FR (8.0 MM)
• 20192253026372: SILICONE OIL COATED LATEX FOLEY CATHETER 5 CC, 2-WAY, 22 FR (7.3 MM)
• 20192253026365: SILICONE OIL COATED LATEX FOLEY CATHETER 5 CC, 2-WAY, 20 FR (6.7 MM)
• 20192253026358: SILICONE OIL COATED LATEX FOLEY CATHETER 5 CC, 2-WAY, 18 FR (6.0 MM)
• 20192253026341: SILICONE OIL COATED LATEX FOLEY CATHETER 5 CC, 2-WAY, 16 FR (5.3 MM)
• 20192253026334: SILICONE OIL COATED LATEX FOLEY CATHETER 5 CC, 2-WAY, 14 FR (4.7 MM)
• 20192253027614: SILICONE ELASTOMER COATED LATEX T.U.R.P FOLEY CATHETER, 30-50 CC, 2-WAY, 22 FR (7.3 MM)