FDA.reportPublic FDA data

EASYMIX® vacuum pump I

Primary DI
04260056881633
Brand
EASYMIX® vacuum pump I
Company
OSARTIS GmbH
Model
02-0401
Catalog number
02-0401
Device description
The devices are used with an EASYMIX® vacuum mixing system to reduce air entrapment in bone cement. The pump is operated with compressed air and generates a vacuum in the connected mixing system. It is a non-sterile, re-usable device to be placed in the non-sterile area on the floor of the operating room.
Published
2022-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JDYEvacuator, Vapor, Cement Monomer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDYEvacuator, Vapor, Cement MonomerOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260056881633PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260056881633042600568816334260056881633

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic material preparation vacuum pumpA pneumatically-powered device intended to create negative pressure (vacuum) during orthopaedic cement/filler mixing to help improve the quality of the resulting cement/filler (e.g., reduced porosity and fatigue). It is typically a portable unit containing a pump with a pressure dial/display and control(s), and is usually used in conjunction with an orthopaedic cement-mixing container and fume evacuation/filtering devices.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
344261631
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260056880674XPERIENCE Advanced Surgical IrrigationSL-0005MC-SL-0005-102026-04-01
04260056880643BLASTX®WG-0001MC-WG.0001-122026-02-19
14260056880640BLASTX®WG-0001MC-WG.0001-122026-02-19
04260056882579BonOs HV1x4001-01622024-05-17
04260056882623BonOs HV Genta1x4001-02622024-04-03
04260056880759Vertecem II Cement Kit08.702.017S08.702.017S2015-10-21
04260056883231BonOs Inject01-03092015-10-02
04260056880612EASYMIX® Nozzle slim02-010402-01042022-12-01
04260056880919EASYMIX® Nozzle revision02-010502-01052022-12-01
14260056880619EASYMIX® Nozzle slim02-010402-01042022-12-01
14260056880916EASYMIX® Nozzle revision02-010502-01052022-12-01
04260056881022EASYMIX® compressed air hose02-020502-02052022-12-01
04260056881039EASYMIX® compressed air hose02-020602-02062022-12-01
04260056881930EASYMIX® vacuum pump II02-020102-02012022-12-01
04260056881251EASYMIX cement injector02-0504-0402-0504-042022-11-28
04260056884412EASYMIX pro02-030502-03052021-11-11
04260056884429EASYMIX pro02-030502-03052021-11-11
04260056881565ManuMix02-060102-06022021-10-12
04260056881572ManuMix02-060102-06022021-10-12
04260056885624BonOs R 1x4001-01172015-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842962102091HNM MEDICALHNM STAINLESS, LLC.JDY2023-05-27
00842962104309HNM MEDICALHNM STAINLESS, LLC.JDY2023-05-27
15060238200148SmartMix Vacuum Footpump and Airhose SUMMIT MEDICAL LIMITEDJDY2023-02-09
15060238200278Summit Medical High Vacuum Footpump + Air HoseSUMMIT MEDICAL LIMITEDJDY2023-02-09
15060238200452SmartMix CemVac Dual Vacuum Footpump & Airhose SUMMIT MEDICAL LIMITEDJDY2023-02-09
04260056881022EASYMIX® compressed air hoseOSARTIS GmbHJDY2022-12-01
04260056881039EASYMIX® compressed air hoseOSARTIS GmbHJDY2022-12-01
04260056881930EASYMIX® vacuum pump IIOSARTIS GmbHJDY2022-12-01
00889024374904NAZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.JDY2021-03-03
04260102131231PALAMIX® Heraeus Medical GmbHJDY2019-05-15
00889024374867NAZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.JDY2019-03-08
00889024374874NAZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.JDY2019-03-08
00889024374881NAZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.JDY2019-03-08
00889024374898NAZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.JDY2019-03-08
00889024376670Miller™Zimmer, Inc.JDY2016-10-10
00889024382107Miller™Zimmer, Inc.JDY2016-10-10