CO-SET+ 93524

GUDID 00690103497143

PROBE,TEMP F/MARQUETTE N/S PART NUMBER 650405005

Edwards Lifesciences LLC

General-purpose patient temperature probe, reusable General-purpose patient temperature probe, reusable

• Primary Device ID: 00690103497143
• NIH Device Record Key: 361f0296-d212-485b-9d64-00983a18ebc5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CO-SET+
• Version Model Number: 93524
• Catalog Number: 93524
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does n
• 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)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com

Device Dimensions

• Length: 78 Inch
• Length: 78 Inch

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	00690103497143 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K811399

FDA Product Code

• KRB: PROBE, THERMODILUTION

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

On-Brand Devices [CO-SET+]

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• 00690103197150: PROBE,TEMP F/MARQUETTE 7000 36IN CABLE N/S PART #650405004
• 00690103004250: INJECTATE TEMPERATURE PROBE
• 00690103003260: CO-SET INJECTATE PROBE CABLE
• 07460691955448: CO - SET MOD ROOM TEMPERATURE STERILE
• 07460691950023: CO-SET+ (DUAL STOPCOCKS) CLOSED INJECTATE DELIVERY SYS
• 07460691950016: CO-SET(R) AND SYRINGE F/USE W/ 93-500,-510,-600,-610 5EA/CA
• 07460691950009: CO-SET DELIVERY SYSTEM FOR 123 ROOM TEMPATURE INJECTATE
• 07460691949997: CO-SET DELIVERY SYSTEM FOR COLD INJECTATE
• 07460691949973: CO-SET HOUSING CASE OF 8
• 00690103197143: PROBE,TEMP F/MARQUETTE N/S PART NUMBER 650405005