Hobbs Inflation Monitor 4630

GUDID M84946300

A non-sterile device designed to monitor the pressure of a balloon catheter being inflated by injecting and aspirating fluid or air within the balloon during a medical procedure. It typically is used in conjunction with a syringe/plunger, a locking mechanism, and a connecting tube for monitoring pressure within the balloon [e.g., in atmosphere(s) (atm) or pounds per square inch (psi)]. This is a single-use device.

HOBBS MEDICAL, INC.

Catheter/overtube balloon inflator, single-use

• Primary Device ID: M84946300
• NIH Device Record Key: 3745d660-3030-4a41-82a7-96e66a53c573
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hobbs Inflation Monitor
• Version Model Number: 4630
• Catalog Number: 4630
• Company DUNS: 076769355
• Company Name: HOBBS MEDICAL, INC.
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8606845875
• Email: customerservice@hobbsmedical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M84946300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K921026

FDA Product Code

• KNT: Tubes, Gastrointestinal (And Accessories)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-05-06
• Device Publish Date: 2016-09-21

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