CO-SET+ 93600

GUDID 07460691949997

CO-SET DELIVERY SYSTEM FOR COLD INJECTATE

Edwards Lifesciences LLC

Thermal-dilution cardiac output unit

• Primary Device ID: 07460691949997
• NIH Device Record Key: dfcbcde4-0a3d-42ee-bcde-2b53890fd583
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CO-SET+
• Version Model Number: 93600
• Catalog Number: 93600
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• 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: true
• Device Combination Product: false
• Single Use: true
• 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

Device Dimensions

• Total Volume: 10 Milliliter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07460691949997 [Primary]
GS1	57460691949992 [Package]; Package: Shipper [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K811399

FDA Product Code

• KRB: PROBE, THERMODILUTION

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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• 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