FDA.reportPublic FDA data

Bowman Perfusion Monitor, 240V

Primary DI
B238H000107110
Brand
Bowman Perfusion Monitor, 240V
Company
HEMEDEX, INC
Model
Model 500
Catalog number
H0001-0711
Device description
Perfusion Monitor, 240V
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DPWFlowmeter, Blood, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPWFlowmeter, Blood, CardiovascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013376000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013376000QFLOW 500 PERFUSION MONITORING SYSTEMHemedex Incorporated2002-05-08DPW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B238H000107110PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, intracranial pressureA small unit dedicated to the detection, measurement, and recording of intracranial pressure (ICP). It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the parameter/information measured and provided by this module.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
128045676
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B238H000036110QFlow 500 2.7mm Drill Bit Kit NAH0000-36112016-09-21
B238H000036120QFlow 500 5.3mm Drill Bit KitNAH0000-36122016-09-21
B238H000007100Bowman Perfusion Monitor, 120VModel 500H0000-07102016-09-21
B238H000016000QFlow 500 Perfusion ProbeNAH0000-16002016-09-21
B238H000036010QFlow 500 Titanium Bolt-Single LumenNAH0000-36012016-09-21
B238H000036020QFlow 500 Titanium Bolt-Dual LumenNAH0000-36022016-09-21
B238H000036310QFlow 500 Titanium Bolt-Single Lumen Bolt Kit NAH0000-36312016-09-21
B238H000036320QFlow 500 Titanium Bolt-Dual Lumen Bolt Kit NAH0000-36322016-09-21
B238H000036420QFlow 500 Titanium Bolt-Dual Lumen Bolt Kit with Introducer NAH0000-36422016-09-21
B238H000036440QFlow 500 Titanium Bolt-Quad Lumen Bolt Kit NAH0000-36442016-09-21
B238H000036810QFlow 500 Bolt Accessory KitNAH0000-36812016-09-23
B238H000036830QFlow 500 Probe Dura Piercer and Introducer KitNAH0000-36832016-09-21
B238H000036840QFlow 500 Quad Lumen Cranial Bolt Large-Lumen Introducer NAH0000-36842016-09-21
B238H000036850QFlow 500 Male-Female Luer CouplerNAH0000-36852016-09-21

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