FDA.reportPublic FDA data

MediMax Tech

Primary DI
00817325023566
Brand
MediMax Tech
Company
MEDIMAX TECH INC.
Model
EvaQMax
Catalog number
EQM-U
Device description
EQM-U : EvaQMax Smoke Evacuation Unit - Each / 1 per Box / Smoke Evacuation Unit // Reusable
Published
2019-04-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FYDApparatus, Exhaust, Surgical
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYDApparatus, Exhaust, SurgicalGeneral, Plastic Surgery2
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192035000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192035000EvaQMax Smoke Evacuation SystemBio Protech, Inc.2019-08-29FYD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817325023566PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817325023566008173250235668173250235660817325023566

GMDN Terms#

Term, Definition table
TermDefinition
Surgical plume evacuation systemA mains electricity (AC-powered) assembly of devices intended to capture smoke generated during open surgical procedures involving tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). It captures the plume (smoke composed of carbonized cell fragments, water vapour, and hydrocarbons from vaporized tissue) near its origin before it becomes dispersed and causes surgical staff respiratory exposure. It consists of a capture tube or wand and four elements to evacuate smoke: user interface, filters, suction source, and exhaust. The system may be mobile (on wheels) and used during closed surgical procedures (e.g., endoscopy, laparoscopy) to clear the view. See also: Gas/fume evacuation system; Anaesthetic gas scavenging unit; Suction system filter, plume particulate; Orthopaedic cement fume evacuator; Surgical plume evacuation system tube

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-633-4629support@medimaxtech.com

Regulatory Flags#

DUNS number
927071162
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00817325023788MediMax TechASFN32020-09-24
00817325023795MediMax TechASFT032020-09-24
00817325023801MediMax TechTS32020-11-16
00817325023818MediMax TechTV32020-11-16
00817325023825MediMax TechTO3 2020-11-16
00817325026574MediMaxTech Inc.MSH22M2024-03-25
10817325023808MediMax TechTS32020-11-16
10817325023815MediMax TechTV32020-11-16
10817325023822MediMax TechTO3 2020-11-16
10817325026571MediMaxTech Inc.MSH22M2024-03-25
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