SWAN-GANZ D200F7

GUDID 00690103147315

SWAN-GANZ PACING TD CATHETER

Edwards Lifesciences LLC

Temporary cardiac pacing balloon catheter Temporary cardiac pacing balloon catheter

• Primary Device ID: 00690103147315
• NIH Device Record Key: 0fff3a8b-b30d-455d-b9dd-f681788f02d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SWAN-GANZ
• Version Model Number: D200F7
• Catalog Number: D200F7
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• 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(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE.
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103147315 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K791183

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-03

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• 00690103161236: CATHETER / INTRODUCER SYSTEM NON-LATEX
• 00690103150438: SWAN-GANZ BIPOLAR PACING CATHETER
• 00690103150421: SWAN-GANZ BIPOLAR PACING CATHETER
• 00690103147315: SWAN-GANZ PACING TD CATHETER
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• 00690103000221: NON-BALLOON DUAL LUMEN OXIMETRY CATHETER
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