Covidien AG

GUDID 27290110066479

TSC 8Fr Blue Tip F400(+/-0.1) Sterile

DEGANIA SILICONE LTD

Temperature-monitoring indwelling urethral drainage catheter

• Primary Device ID: 27290110066479
• NIH Device Record Key: 9ff8e8ce-88c7-4f2b-95cf-bea320eb8b8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Covidien AG
• Version Model Number: 102201100880TY
• Company DUNS: 600007082
• Company Name: DEGANIA SILICONE LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: true
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290110066475 [Primary]
GS1	27290110066479 [Package]; Contains: 07290110066475; Package: Box [10 Units]; In Commercial Distribution
GS1	47290110066473 [Package]; Package: Carton [10 Units]; In Commercial Distribution

FDA Product Code

• EZL: Catheter, Retention Type, Balloon

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: 2025-02-28
• Device Publish Date: 2025-02-20

On-Brand Devices [Covidien AG]

• 27290110066523: TSC 18Fr Blue Tip F400(+/-0.1) Sterile
• 27290110066509: TSC 14Fr Blue Tip F400(+/-0.1) Sterile
• 27290110066493: TSC CATHETER CLEAR 12FR STERILE
• 27290110066486: TSC 10Fr Blue Tip F400(+/-0.1) Sterile
• 27290110066479: TSC 8Fr Blue Tip F400(+/-0.1) Sterile
• 27290110066516: TSC 16Fr Blue Tip F400(+/-0.1) Sterile