SJM™ IBI-85786

GUDID 05414734309080

IRVINE BIOMEDICAL, INC.

Electrical catheter connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable

• Primary Device ID: 05414734309080
• NIH Device Record Key: a717f41c-e289-4bbe-9b86-f1d2e76c1fdd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SJM™
• Version Model Number: IBI-85786
• Catalog Number: IBI-85786
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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

Device Dimensions

• Length: 20 Feet
• Length: 20 Feet
• Length: 20 Feet
• Length: 20 Feet
• Length: 20 Feet
• Length: 20 Feet
• Length: 20 Feet
• Length: 20 Feet
• Length: 20 Feet
• Length: 20 Feet
• Length: 20 Feet
• Length: 20 Feet
• Length: 20 Feet
• Length: 20 Feet
• Length: 20 Feet
• Length: 20 Feet
• Length: 20 Feet

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep in a cool, dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734309080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P060019

FDA Product Code

• OAD: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-01-28
• Device Publish Date: 2014-10-31

On-Brand Devices [SJM™]

• 05414734309349: 1914-SA
• 05414734309332: 1910-SA
• 05414734309318: 1904-SA
• 05414734309172: 1924-S
• 05414734309165: 1910-S
• 05414734309110: 1804-S
• 05414734309080: IBI-85786
• 05414734309073: 1778-E
• 05414734309059: 1776
• 05414734308977: 1763-E
• 05414734308939: 1739-W
• 05414734308854: 1713-W
• 05414734308847: 1711-M
• 05414734308830: 1710
• 05414734308755: 1641