FDA.reportPublic FDA data

SmartMix Vacuum Footpump and Airhose

Primary DI
15060238200148
Brand
SmartMix Vacuum Footpump and Airhose
Company
SUMMIT MEDICAL LIMITED
Model
5401-96-500
Device description
SmartMix Vacuum Footpump and Airhose
Published
2023-02-09
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
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
15060238200148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1506023820014815060238200148

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

Contacts#

Phone, Email table
PhoneEmail
+441451821311info@summit-medical.co.uk

Regulatory Flags#

DUNS number
221751311
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15060238201923Vacuum Cement Mixing Bowl1400-21001400-21002025-11-18
25060238201920Vacuum Cement Mixing Bowl1400-21001400-21002025-11-18
15060238201138CellTrans ABT45102018-12-21
15060238201329Spatula & Curette PackSC012022-08-23
15060238201596Femoral Cement PressuriserP721P7212025-01-10
15060238201633HiVac™ 7 Triple Mix C703C7032025-01-10
15060238201657HiVac™ 7 with Femoral Cement Pressuriser CP701CP7012025-01-10
15060238201671HiVac™ SyringeS727S7272025-01-10
15060238201688HiVac™ SyringeS717WS717W2025-01-10
150602382017189mm Nozzle With Nozzle ExtruderN700N7002025-01-10
15060238201725Quick-Vac® Vacuum Mixing Bowl00504900100005049001002025-01-10
15060238201732Quick-Vac® Vacuum Mixing Bowl00504900115005049001152025-01-10
15060238201749HiVac BowlB713B7132025-01-10
15060238201756Rally™ Vacuum Mixing Bowl7127-18017127-18012025-01-10
15060238201770Cement Mixing and Delivery System00-4501-090-0000-4501-090-002025-01-10
15060238201787 MiniMix™SMMM1SMMM12025-01-10
15060238201794MiniMix™ LVSMLVSMLV2025-01-10
15060238201800MiniMix™ Delivery SyringeSMDS1CSMDS1C2025-01-10
15060238201886Mixing bowl, SpatulaB710B7102025-01-10
25060238201593Femoral Cement PressuriserP721P7212025-01-10

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
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
04260056881633EASYMIX® vacuum pump IOSARTIS 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