TB TBK04110USG

GUDID 00836559009030

Oscor Inc.

Atrial cardioversion system catheter

• Primary Device ID: 00836559009030
• NIH Device Record Key: cfda58fb-b9a3-4c1e-9c3c-65c6aa6656b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TB
• Version Model Number: TBK04110USG
• Catalog Number: TBK04110USG
• Company DUNS: 101835833
• Company Name: Oscor 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00836559009030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K861403

FDA Product Code

• LDF: Electrode, Pacemaker, Temporary

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: 2018-08-07
• Device Publish Date: 2015-10-16

On-Brand Devices [TB]

• 00885672103682: Temporary Pacing Lead Convenience Kit, 6F, Right Heart Curve Unshrouded
• 00885672103675: Temporary Pacing Lead Convenience Kit, 6F, Right Heart Curve Shrouded
• 00885672007034: Temporary Pacing Lead Convenience Kit, 4F, J Curve Unshrouded
• 00885672007027: Temporary Pacing Lead Convenience Kit, 4F, 60° Curve Unshrouded
• 00885672004392: Temporary Pacing Lead Convenience Kit, 5F, Right Heart Curve Unshrouded
• 00885672004385: Temporary Pacing Lead Convenience Kit, 5F, Right Heart Curve Shrouded
• 00885672004378: Temporary Pacing Lead Convenience Kit, 4F, Right Heart Curve Unshrouded
• 00885672004361: Temporary Pacing Lead Convenience Kit, 4F, Right Heart Curve Shrouded
• 00885672004354: Temporary Pacing Lead Convenience Kit, 6F, 60° Curve Unshrouded
• 00885672004347: Temporary Pacing Lead Convenience Kit, 6F, 60° Curve Shrouded
• 00836559009924: 020024
• 00836559009917: 020023
• 00836559009900: 020022
• 00836559009894: 020021
• 00836559009887: 020020
• 00836559009870: 020019
• 00836559009863: 020018
• 00836559009856: 020017
• 00836559009849: 020016
• 00836559009832: 020015
• 00836559009825: 020014
• 00836559009818: 020013
• 00836559009801: 020012
• 00836559009795: 020011
• 00836559009788: 020010
• 00836559009771: 020009
• 00836559009764: 020008
• 00836559009757: 020007
• 00836559009740: 020006
• 00836559009733: 020005
• 00836559009726: 020004
• 00836559009719: 020003
• 00836559009702: 020002
• 00836559009696: 020001
• 00836559009078: TBK06110USG
• 00836559009061: TBK06110SSG
• 00836559009054: TBK05110USG
• 00836559009047: TBK05110SSG
• 00836559009030: TBK04110USG
• 00836559009023: TBK04110SSG