Zoom™ 6F Insert Catheter, SIM IC6FSIM143

GUDID 00812212030696

Zoom™ 6F Insert Catheter, SIM, 143cm

IMPERATIVE CARE, INC.

Angiographic catheter, single-use

• Primary Device ID: 00812212030696
• NIH Device Record Key: 2efe8148-178d-4999-94fe-63a7b6c9ec13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zoom™ 6F Insert Catheter, SIM
• Version Model Number: IC6FSIM143
• Catalog Number: IC6FSIM143
• Company DUNS: 080816678
• Company Name: IMPERATIVE CARE, INC.
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-408-502-7548
• Email: CustomerService@Imperativecare.com
• Phone: 1-408-502-7548
• Email: CustomerService@Imperativecare.com
• Phone: 1-408-502-7548
• Email: CustomerService@Imperativecare.com
• Phone: 1-408-502-7548
• Email: CustomerService@Imperativecare.com
• Phone: 1-408-502-7548
• Email: CustomerService@Imperativecare.com
• Phone: 1-408-502-7548
• Email: CustomerService@Imperativecare.com
• Phone: 1-408-502-7548
• Email: CustomerService@Imperativecare.com
• Phone: 1-408-502-7548
• Email: CustomerService@Imperativecare.com
• Phone: 1-408-502-7548
• Email: CustomerService@Imperativecare.com
• Phone: 1-408-502-7548
• Email: CustomerService@Imperativecare.com
• Phone: 1-408-502-7548
• Email: CustomerService@Imperativecare.com
• Phone: 1-408-502-7548
• Email: CustomerService@Imperativecare.com
• Phone: 1-408-502-7548
• Email: CustomerService@Imperativecare.com
• Phone: 1-408-502-7548
• Email: CustomerService@Imperativecare.com

Device Dimensions

• Catheter Length: 143 Centimeter
• Outer Diameter: 0.082 Inch
• Lumen/Inner Diameter: 0.041 Inch
• Catheter Length: 143 Centimeter
• Outer Diameter: 0.082 Inch
• Lumen/Inner Diameter: 0.041 Inch
• Catheter Length: 143 Centimeter
• Outer Diameter: 0.082 Inch
• Lumen/Inner Diameter: 0.041 Inch
• Catheter Length: 143 Centimeter
• Outer Diameter: 0.082 Inch
• Lumen/Inner Diameter: 0.041 Inch
• Catheter Length: 143 Centimeter
• Outer Diameter: 0.082 Inch
• Lumen/Inner Diameter: 0.041 Inch
• Catheter Length: 143 Centimeter
• Outer Diameter: 0.082 Inch
• Lumen/Inner Diameter: 0.041 Inch
• Catheter Length: 143 Centimeter
• Outer Diameter: 0.082 Inch
• Lumen/Inner Diameter: 0.041 Inch
• Catheter Length: 143 Centimeter
• Outer Diameter: 0.082 Inch
• Lumen/Inner Diameter: 0.041 Inch
• Catheter Length: 143 Centimeter
• Outer Diameter: 0.082 Inch
• Lumen/Inner Diameter: 0.041 Inch
• Catheter Length: 143 Centimeter
• Outer Diameter: 0.082 Inch
• Lumen/Inner Diameter: 0.041 Inch
• Catheter Length: 143 Centimeter
• Outer Diameter: 0.082 Inch
• Lumen/Inner Diameter: 0.041 Inch
• Catheter Length: 143 Centimeter
• Outer Diameter: 0.082 Inch
• Lumen/Inner Diameter: 0.041 Inch
• Catheter Length: 143 Centimeter
• Outer Diameter: 0.082 Inch
• Lumen/Inner Diameter: 0.041 Inch
• Catheter Length: 143 Centimeter
• Outer Diameter: 0.082 Inch
• Lumen/Inner Diameter: 0.041 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812212030696 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233975

FDA Product Code

• DQO: Catheter, Intravascular, Diagnostic

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: 2024-06-26
• Device Publish Date: 2024-06-18

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