GENTLECATH GLIDE

GUDID 00768455168569

GentleCath™ Glide Intermittent Urinary Catheter

CONVATEC, PURCHASING DEPARTMENT

Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter Single-administration urethral drainage catheter

• Primary Device ID: 00768455168569
• NIH Device Record Key: 0350f8e1-aa40-4fbc-9b12-d4218c8a7106
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GENTLECATH GLIDE
• Version Model Number: 510472
• Company DUNS: 809784593
• Company Name: CONVATEC, PURCHASING DEPARTMENT
• 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

Customer Support Contacts

• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00768455168569 [Package]; Contains: 00768455168736; Package: Sample Pack [10 Units]; In Commercial Distribution
GS1	00768455168736 [Primary]
GS1	00768455168903 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181206

FDA Product Code

• GBM: CATHETER, URETHRAL

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: 2023-11-07
• Device Publish Date: 2023-10-30

On-Brand Devices [GENTLECATH GLIDE]

• 00768455205417: GentleCath Glide Female CH16 (1x30pk)
• 00768455205400: GentleCath Glide Female CH14 (1x30pk)
• 00768455205394: GentleCath Glide Female CH12 (1x30pk)
• 00768455202300: GentleCath Glide Female CH10 (1x30pk)
• 00768455202294: GentleCath Glide Female CH08 (1x30pk)
• 00768455202287: GentleCath Glide Male CH18 (1x30pk)
• 00768455205356: GentleCath Glide Male CH16 (1x30pk)
• 00768455205349: GentleCath Glide Male CH14 (1x30pk)
• 00768455205332: GentleCath Glide Male CH12 (1x30pk)
• 00768455202249: GentleCath Glide Male CH10 (1x30pk)
• 00768455205318: GentleCath Glide Male CH08 (1x30pk)
• 00768455169030: GentleCath™ Glide Intermittent Urinary Catheter
• 00768455169023: GentleCath™ Glide Intermittent Urinary Catheter
• 00768455168675: GentleCath Glide
• 00768455169009: GentleCath Glide Femenino CH10
• 00768455168651: GentleCath™ Glide Intermittent Urinary Catheter
• 00768455168644: GentleCath™ Glide Intermittent Urinary Catheter
• 00768455168613: GentleCath™ Glide Intermittent Urinary Catheter
• 00768455168941: GentleCath™ Glide Intermittent Urinary Catheter
• 00768455168590: GentleCath™ Glide Intermittent Urinary Catheter
• 00768455168927: GentleCath™ Glide Intermittent Urinary Catheter
• 00768455168910: GentleCath™ Glide Intermittent Urinary Catheter
• 00768455168569: GentleCath™ Glide Intermittent Urinary Catheter
• 00768455168545: GentleCath Glide Tiemann CH10
• 00768455168873: GentleCath™ Glide Intermittent Urinary Catheter
• 00768455168552: GentleCath™ Glide Intermittent Urinary Catheter