ViewFlex™ D087031

GUDID 05415067002082

IRVINE BIOMEDICAL, INC.

Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use

• Primary Device ID: 05415067002082
• NIH Device Record Key: 84da4bfd-2b29-486a-b5df-3dd77fd456bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ViewFlex™
• Version Model Number: Xtra
• Catalog Number: D087031
• Company DUNS: 926346966
• Company Name: IRVINE BIOMEDICAL, 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: true
• 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: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Device Dimensions

• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French
• Catheter Gauge: 9 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 79 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry, keep away from sunlight, and protect from heat and radioactive sources.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067002082 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133853

FDA Product Code

• OBJ: Catheter, ultrasound, intravascular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-07-22
• Device Publish Date: 2016-01-12

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