Thermodilution 7FR 110cm Modified J-tip 474-110P

GUDID M822474110P0

Thermodilution Catheter

ALPHA MEDICAL INSTRUMENTS

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• Primary Device ID: M822474110P0
• NIH Device Record Key: 717caa6b-8e83-48c0-9e36-86ac55af8090
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thermodilution 7FR 110cm Modified J-tip
• Version Model Number: 474-110P
• Catalog Number: 474-110P
• Company DUNS: 627767577
• Company Name: ALPHA MEDICAL INSTRUMENTS
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 949-460-0944
• Email: info@alphamedicalinstruments.com
• Phone: 949-460-0944
• Email: info@alphamedicalinstruments.com
• Phone: 949-460-0944
• Email: info@alphamedicalinstruments.com
• Phone: 949-460-0944
• Email: info@alphamedicalinstruments.com
• Phone: 949-460-0944
• Email: info@alphamedicalinstruments.com
• Phone: 949-460-0944
• Email: info@alphamedicalinstruments.com
• Phone: 949-460-0944
• Email: info@alphamedicalinstruments.com
• Phone: 949-460-0944
• Email: info@alphamedicalinstruments.com
• Phone: 949-460-0944
• Email: info@alphamedicalinstruments.com
• Phone: 949-460-0944
• Email: info@alphamedicalinstruments.com
• Phone: 949-460-0944
• Email: info@alphamedicalinstruments.com
• Phone: 949-460-0944
• Email: info@alphamedicalinstruments.com
• Phone: 949-460-0944
• Email: info@alphamedicalinstruments.com
• Phone: 949-460-0944
• Email: info@alphamedicalinstruments.com
• Phone: 949-460-0944
• Email: info@alphamedicalinstruments.com
• Phone: 949-460-0944
• Email: info@alphamedicalinstruments.com
• Phone: 949-460-0944
• Email: info@alphamedicalinstruments.com
• Phone: 949-460-0944
• Email: info@alphamedicalinstruments.com
• Phone: 949-460-0944
• Email: info@alphamedicalinstruments.com
• Phone: 949-460-0944
• Email: info@alphamedicalinstruments.com
• Phone: 949-460-0944
• Email: info@alphamedicalinstruments.com
• Phone: 949-460-0944
• Email: info@alphamedicalinstruments.com
• Phone: 949-460-0944
• Email: info@alphamedicalinstruments.com
• Phone: 949-460-0944
• Email: info@alphamedicalinstruments.com
• Phone: 949-460-0944
• Email: info@alphamedicalinstruments.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M822474110P0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K920869

FDA Product Code

• DYG: Catheter, Flow Directed

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: 2019-12-11
• Device Publish Date: 2016-10-08

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