Angiographic 5fr 80cm C-tip 252-80P

GUDID M82225280P2

Angiographic Balloon Catheter

ALPHA MEDICAL INSTRUMENTS

Pulmonary artery catheter, standard Pulmonary artery balloon catheter, standard Pulmonary artery balloon catheter, standard Pulmonary artery balloon catheter, standard Pulmonary artery balloon catheter, standard Pulmonary artery balloon catheter, standard Pulmonary artery balloon catheter, standard Pulmonary artery balloon catheter, standard Pulmonary artery balloon catheter, standard Pulmonary artery balloon catheter, standard Pulmonary artery balloon catheter, non-electrical Pulmonary artery balloon catheter, non-electrical Pulmonary artery balloon catheter, non-electrical Pulmonary artery balloon catheter, non-electrical Pulmonary artery balloon catheter, non-electrical Pulmonary artery balloon catheter, non-electrical Pulmonary artery balloon catheter, non-electrical Pulmonary artery balloon catheter, non-electrical Pulmonary artery balloon catheter, non-electrical Pulmonary artery balloon catheter, non-electrical Pulmonary artery balloon catheter, non-electrical Pulmonary artery balloon catheter, non-electrical Pulmonary artery balloon catheter, non-electrical Pulmonary artery balloon catheter, non-electrical Pulmonary artery balloon catheter, non-electrical

• Primary Device ID: M82225280P2
• NIH Device Record Key: cece1314-eef8-4507-9be1-01287368095a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Angiographic 5fr 80cm C-tip
• Version Model Number: 252-80P
• Catalog Number: 252-80P
• Company DUNS: 627767577
• Company Name: ALPHA MEDICAL INSTRUMENTS
• Device Count: 1
• DM Exempt: true
• 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: 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	M82225280P2 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K920870

FDA Product Code

• DQO: Catheter, Intravascular, Diagnostic

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: 2016-11-10

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