ZOOM™ RDL Radial Access System, 110cm ICTC088110R

GUDID 00812212030535

ZOOM™ RDL, 110cm with dilator

IMPERATIVE CARE, INC.

Vascular guide-catheter, single-use

• Primary Device ID: 00812212030535
• NIH Device Record Key: e89d26c0-6262-45a3-a147-6bba1da4c9a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZOOM™ RDL Radial Access System, 110cm
• Version Model Number: ICTC088110R
• Catalog Number: ICTC088110R
• 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
• Phone: 1-408-502-7548
• Email: CustomerService@Imperativecare.com

Device Dimensions

• Lumen/Inner Diameter: 0.088 Inch
• Outer Diameter: 0.11 Inch
• Catheter Length: 110 Centimeter
• Lumen/Inner Diameter: 0.088 Inch
• Outer Diameter: 0.11 Inch
• Catheter Length: 110 Centimeter
• Lumen/Inner Diameter: 0.088 Inch
• Outer Diameter: 0.11 Inch
• Catheter Length: 110 Centimeter
• Lumen/Inner Diameter: 0.088 Inch
• Outer Diameter: 0.11 Inch
• Catheter Length: 110 Centimeter
• Lumen/Inner Diameter: 0.088 Inch
• Outer Diameter: 0.11 Inch
• Catheter Length: 110 Centimeter
• Lumen/Inner Diameter: 0.088 Inch
• Outer Diameter: 0.11 Inch
• Catheter Length: 110 Centimeter
• Lumen/Inner Diameter: 0.088 Inch
• Outer Diameter: 0.11 Inch
• Catheter Length: 110 Centimeter
• Lumen/Inner Diameter: 0.088 Inch
• Outer Diameter: 0.11 Inch
• Catheter Length: 110 Centimeter
• Lumen/Inner Diameter: 0.088 Inch
• Outer Diameter: 0.11 Inch
• Catheter Length: 110 Centimeter
• Lumen/Inner Diameter: 0.088 Inch
• Outer Diameter: 0.11 Inch
• Catheter Length: 110 Centimeter
• Lumen/Inner Diameter: 0.088 Inch
• Outer Diameter: 0.11 Inch
• Catheter Length: 110 Centimeter
• Lumen/Inner Diameter: 0.088 Inch
• Outer Diameter: 0.11 Inch
• Catheter Length: 110 Centimeter
• Lumen/Inner Diameter: 0.088 Inch
• Outer Diameter: 0.11 Inch
• Catheter Length: 110 Centimeter
• Lumen/Inner Diameter: 0.088 Inch
• Outer Diameter: 0.11 Inch
• Catheter Length: 110 Centimeter
• Lumen/Inner Diameter: 0.088 Inch
• Outer Diameter: 0.11 Inch
• Catheter Length: 110 Centimeter

Operating and Storage Conditions

• 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.
• 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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812212030535 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220807

FDA Product Code

• DQY: Catheter, Percutaneous

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: 2022-10-06
• Device Publish Date: 2022-09-28

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