N/A C10MR10MSTKS

GUDID 10846835000184

BIOSENSE WEBSTER INC.

Electrical-only medical device connection cable, reusable

• Primary Device ID: 10846835000184
• NIH Device Record Key: dc9ec1d5-90d4-4c98-9968-f7e112741e17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: C10MR10MSTKS
• Catalog Number: C10MR10MSTKS
• Company DUNS: 020163218
• Company Name: BIOSENSE WEBSTER 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: 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(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com
• Phone: +1(800)729-9010
• Email: RA-BWIUS-Complaints@its.jnj.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry | Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is opened
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	10846835000184 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P010068

FDA Product Code

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

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: 2021-01-15
• Device Publish Date: 2017-09-13

On-Brand Devices [N/A]

• 10846835008913: D128709
• 10846835008890: D128623
• 10846835008647: OF63X4C010FS
• 10846835005592: D7DL252PS
• 10846835005073: D7AL252PS
• 10846835003680: C6MR10EPTST
• 10846835003666: C6MR10EPTRS
• 10846835003628: C6FST6MST6
• 10846835003420: C3FFMST12X
• 10846835003413: C3FFMST10X
• 10846835003406: C10MRMSTKDTCS
• 10846835000214: C5MHREFMHS
• 10846835000207: C5MHNAVMHS
• 10846835000191: C5MHDTCMHS
• 10846835000184: C10MR10MSTKS
• 10846835006353: D8BRFL252RT
• 10846835006322: D8BRDL252RT
• 10846835006292: D8BRCG252RT
• 10846835005912: D7PSL252RT
• 10846835005714: D7FL252RT
• 10846835005684: D7EL252RT
• 10846835005660: D7EG252RT
• 10846835005608: D7DL252RT
• 10846835005554: D7CL252RT
• 10846835005530: D7CG252RT
• 10846835005110: D7BL252RT
• 10846835005080: D7AL252RT
• 10846835003697: C6MR10MLTCS
• 10846835001839: 116409RT
• 10846835002393: AMSTK
• 10846835002386: AESTK
• 10846835002379: ADSTK