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 IDM84946300
NIH Device Record Key3745d660-3030-4a41-82a7-96e66a53c573
Commercial Distribution StatusIn Commercial Distribution
Brand NameHobbs Inflation Monitor
Version Model Number4630
Catalog Number4630
Company DUNS076769355
Company NameHOBBS MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8606845875
Emailcustomerservice@hobbsmedical.com
Phone8606845875
Emailcustomerservice@hobbsmedical.com
Phone8606845875
Emailcustomerservice@hobbsmedical.com
Phone8606845875
Emailcustomerservice@hobbsmedical.com
Phone8606845875
Emailcustomerservice@hobbsmedical.com
Phone8606845875
Emailcustomerservice@hobbsmedical.com
Phone8606845875
Emailcustomerservice@hobbsmedical.com
Phone8606845875
Emailcustomerservice@hobbsmedical.com
Phone8606845875
Emailcustomerservice@hobbsmedical.com
Phone8606845875
Emailcustomerservice@hobbsmedical.com
Phone8606845875
Emailcustomerservice@hobbsmedical.com
Phone8606845875
Emailcustomerservice@hobbsmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM84946300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNTTubes, Gastrointestinal (And Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-05-06
Device Publish Date2016-09-21

Devices Manufactured by HOBBS MEDICAL, INC.

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