FDA.reportPublic FDA data

sensor

Primary DI
04250337119968
Brand
sensor
Company
Joimax GmbH
Model
JIXPSEN03
Catalog number
JIXPSEN03
Device description
joimax® Sensors
Published
2022-12-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQHLAVAGE, JET

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQHLavage, JetGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250337119968PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250337119968042503371199684250337119968

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation pumpAn electrically-powered device, which may include noninvasive accessories, intended to pump a sterile fluid (e.g., saline water) to irrigate body cavities/wounds during surgery (e.g., general surgery, endoscopic). It is typically intended to be used to wash away tissues/fluids/debris with a sterile fluid to facilitate observation; it is not intended to administer parenteral fluids or drugs and is not capable of suction. The device may incorporate a display and may include collection containers or tubing; it does not include patient contact devices (e.g., handpiece/tip, catheter).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+497212551407010info@joimax.com

Regulatory Flags#

DUNS number
344267187
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250337118022Intracs®JINTST15JINTST152022-12-30
04250337118039Intracs®JINTST18JINTST182022-12-30
04250337118046Intracs®JINTST23JINTST232022-12-30
04250337116530Joimax® Intracs® EM System Integrated Navigation Tracking & Control SystemJINT01S2021-11-12
04250337116547Joimax® Intracs® EM Panel PCJINTPC11052021-11-12
04250337116554Joimax® Intracs® EM Control UnitJINTCU11152021-11-12
04250337116561Joimax® Intracs® EM Field GeneratorJINTFG11252021-11-12
04250337116585Joimax® Intracs® EM Patient TrackerJINTPT22352021-11-12
04250337116592Joimax® Intracs® EM Sensor ClipJINTSC22052021-11-12
04250337116608Joimax® Intracs® EM Sensor Wire 150JINTSW22152021-11-12
04250337116615Joimax® Intracs® EM Sensor Wire 180JINTSW22182021-11-12
04250337116622Joimax® Intracs® EM Sensor Wire 230JINTSW22232021-11-12
04250337116646Joimax® Intracs® EM Mounting Arm f field Generator mounting arm + rail clampJINTMA11352021-11-12
04250337117667Joimax® Intracs® EM Mounting Arm f. Patient Mapper mounting arm + rail clampJINTMAP11362021-11-12
04250337117988Wire cutterJINTWC2021-11-12
04250337117995Joimax® Intracs® EM Y-AdapterJINTYA352021-11-12
04250337118008Joimax® Intracs® EM K-Wire Drill Guide W 18 mm x D 28 mm x H 60 mmJINTDG1828602021-11-12
04250337118015K-Wire w/ thread, Trocar w. 15 mm thread, round 1.5 mm x 150 mmJKW15152021-11-12
04250337118213Joimax® Intracs® EM Patient Mapper - APJINTPM2245-AP2021-11-12
04250337118220Joimax® Intracs® EM Patient Mapper - LATJINTPM2245-LAT2021-11-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260056880636BactisureOSARTIS GmbHFQH2026-08-25
00850022135316VeriCyn Wound WashArmis Biopharma, Inc.FQH2026-07-30
00850022135330VeriCyn Wound WashArmis Biopharma, Inc.FQH2026-07-30
00850022135347VeriCyn Wound WashArmis Biopharma, Inc.FQH2026-07-30
05051471221512De Soutter MedicalDE SOUTTER MEDICAL LIMITEDFQH2026-05-27
B674PL30010PerilavStiehl Tech, LLCFQH2026-05-13
B674T93LF10PerilavStiehl Tech, LLCFQH2026-05-13
07640407460811debritom+Medaxis AGFQH2026-04-17
07649996166302debritom+Medaxis AGFQH2026-04-17
07649996166043debritom+Medaxis AGFQH2026-04-08
00382909101201SurgiphorCAREFUSION 2200, INCFQH2026-03-05
00075450844337Hy-Vee Saline Wound WashHY-VEE, INC.FQH2026-02-19
00850073677032Shur-ClensAsept Pak, Inc.FQH2026-02-17
00850073677056Skin-ClensAsept Pak, Inc.FQH2026-02-17
10850073677008Shur-ClensAsept Pak, Inc.FQH2025-04-30
10860006476035Shur-ClensAsept Pak, Inc.FQH2025-04-23
10850073677015Shur-ClensAsept Pak, Inc.FQH2025-04-16
10860006476028Shur-ClensAsept Pak, Inc.FQH2025-04-16
10842351180027Irrisept Accessory KitIRRIMAX CORPORATIONFQH2024-07-22
10842351120047Irrisept Antimicrobial Wound LavageIRRIMAX CORPORATIONFQH2024-07-16
10842351180010Irrisept Wound Solution KitIRRIMAX CORPORATIONFQH2024-07-01
06951233720125CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720170CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720316CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720330CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720361CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720378palaJet ®Guangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720507palaJet ®Guangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720545CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720569PulsaCleanGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11