FDA.reportPublic FDA data

Electro Flo® Percussor

Primary DI
00862528000302
Brand
Electro Flo® Percussor
Company
MED SYSTEMS INC
Model
5000
Device description
The Electro Flo 5000 is an electrically powered percussor, intended to assist in airway clearance therapy when the physician’s choice of therapy is external manipulation of the thorax. Additionally, the Electro Flo 5000 is indicated for external manipulation of the thorax to promote airway clearance and improve bronchial drainage.
Published
2019-03-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYIPercussor, Powered-Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYIPercussor, Powered-ElectricAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031876000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031876000ELECTRO FLO PERCUSSOR, MODEL 5000Med Systems2003-11-21BYI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00862528000302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862528000302008625280003028625280003020862528000302

GMDN Terms#

Term, Definition table
TermDefinition
Chest-percussion airway secretion-clearing system control unitA mains electricity (AC-powered) component of a chest-percussion airway secretion-clearing system designed to regulate the amount of power delivered to the system's applicator and the speed at which the percussion is delivered.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature50 Degrees Fahrenheit90 Degrees Fahrenheit
Storage Environment Temperature32 Degrees Fahrenheit158 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
858 483-9671susan@medsystems.com

Regulatory Flags#

DUNS number
039978200
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00862528000319FluidFlo250025002023-09-05
00862528000326Med Systems small mask.210121012023-09-05
00862528000333Med Systems medium mask.210221022023-09-05
00862528000340Med Systems large mask.210321032023-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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