Wedge Pressure  6fr 80cm Modified J-tip 162-80P

GUDID M82216280P2

Wedge Pressure Balloon Catheter

ALPHA MEDICAL INSTRUMENTS

Pulmonary artery catheter, standard

• Primary Device ID: M82216280P2
• NIH Device Record Key: b10e2117-6079-40f8-a0c3-7a354b93e8e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wedge Pressure 6fr 80cm Modified J-tip
• Version Model Number: 162-80P
• Catalog Number: 162-80P
• 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	M82216280P2 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K920873

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: 2016-10-08

Devices Manufactured by ALPHA MEDICAL INSTRUMENTS

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• M82214260P2 - Wedge Pressure 4fr 60cm Modified J-tip: 2019-12-11 Wedge Pressure Balloon Catheter
• M822152110P0 - Wedge Pressure 5fr 110cm Modified J-tip(Standard-tip): 2019-12-11 Wedge Pressure Catheter
• M82215260P2 - Wedge Pressure 5fr 60cm Modified J-tip: 2019-12-11 Wedge Pressure Balloon Catheter
• M822162110PS0 - Wedge Pressure 6fr 110cm S-tip: 2019-12-11 Wedge Pressure Catheter
• M82216280P0 - Wedge Pressure 6fr 110cm Standard Tip: 2019-12-11 Wedge Pressure Catheter
• M82216280P2 - Wedge Pressure 6fr 80cm Modified J-tip: 2019-12-11Wedge Pressure Balloon Catheter
• M82216280P2 - Wedge Pressure 6fr 80cm Modified J-tip: 2019-12-11 Wedge Pressure Balloon Catheter
• M822172110PS2 - Wedge Pressure 7fr 110cm S-tip: 2019-12-11 Wedge Pressure Balloon Catheter