FDA.reportPublic FDA data

MULTISTIM VARIO

Primary DI
04048223115787
Brand
MULTISTIM VARIO
Company
Pajunk GmbH Medizintechnologie
Model
1151-94-05
Catalog number
1151-94-05
Device description
1151-94-05
Published
2021-07-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
BXNSTIMULATOR, NERVE, BATTERY-POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXNStimulator, Nerve, Battery-PoweredAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048223075791PreviousGS10
04048223115787PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048223075791040482230757914048223075791
04048223115787040482231157874048223115787

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity65 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 770-493-6832info@pajunk-usa.com

Regulatory Flags#

DUNS number
317654283
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048223084366EpiLong Soft NRFit1432167-511432167-512026-05-21
04048223122235Stim2Go9151-10-009151-10-002026-05-21
04048223126103NerveStim Pure1151-94-901151-94-902026-02-06
14048223031312NiniFilter NRFit001163-38K001163-38K2020-07-22
14048223041793Filter NRFit001163-39F001163-39F2020-07-22
04048223048917FILTER001151-37X001151-37X2021-04-02
04048223049877FILTER001163-38K001163-38K2021-04-02
04048223050064FILTER001163-39F001163-39F2021-04-02
04048223069462Flat filter 0,2µm round001151-37Q001151-37Q2025-01-30
04048223069585MiniFilter 0,2µm001151-38K001151-38K2025-01-30
04048223070598Filter cannula NRFit001163-38Y001163-38Y2025-01-30
04048223120316Filter001151-62001151-622025-04-04
14048223016593Filter 0,2µm001151-37X001151-37X2016-09-29
14048223018993Quincke1149-3E1201149-3E1202020-11-03
14048223032777Tuohy cannula1150-7G1031150-7G1032020-06-09
14048223034443Tuohy1150-4G1031150-4G1032020-11-16
14048223036720UniMSK1192-4E1201192-4E1202020-07-02
14048223036737UniMSK1192-4E1501192-4E1502020-07-02
14048223038946Tuohy1150-4E1201150-4E1202020-05-06
14048223038953Tuohy1150-4G1201150-4G1202020-07-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048223126103NerveStim PurePajunk GmbH MedizintechnologieBXN2026-02-06
06009880396443BIOVENTUSXAVANT TECHNOLOGY (PTY) LTDBXN2025-07-30
06009880396184BIONESSXAVANT TECHNOLOGY (PTY) LTDBXN2025-02-17
06009880396191BIONESSXAVANT TECHNOLOGY (PTY) LTDBXN2025-02-17
04048223093931ExtensionCable 60cmPajunk GmbH MedizintechnologieBXN2025-01-30
04048223103784ExtensionCable 60cmPajunk GmbH MedizintechnologieBXN2025-01-30
06009880396177STIMPODXAVANT TECHNOLOGY (PTY) LTDBXN2024-11-15
06009880396429STIMPODXAVANT TECHNOLOGY (PTY) LTDBXN2024-11-15
06009880396870Xavant TechnologyXAVANT TECHNOLOGY (PTY) LTDBXN2023-12-23
10889483000014SunMedSUNMED, LLCBXN2023-08-01
10889483171127SunMedSUNMED, LLCBXN2023-08-01
10889483171394SunMedSUNMED, LLCBXN2023-08-01
10889483171417SunMedSUNMED, LLCBXN2023-08-01
10889483171424SunMedSUNMED, LLCBXN2023-08-01
10889483171431SunMedSUNMED, LLCBXN2023-08-01
10889483171448SunMedSUNMED, LLCBXN2023-08-01
10889483171455SunMedSUNMED, LLCBXN2023-08-01
10889483171462SunMedSUNMED, LLCBXN2023-08-01
10889483171479SunMedSUNMED, LLCBXN2023-08-01
10889483171486SunMedSUNMED, LLCBXN2023-08-01
10889483171844SunMedSUNMED, LLCBXN2023-08-01
06009880396573STIMPODXAVANT TECHNOLOGY (PTY) LTDBXN2022-12-08
04048223115794MULTISTIM VARIOPajunk GmbH MedizintechnologieBXN2022-11-21
06009880396696STIMPODXAVANT TECHNOLOGY (PTY) LTDBXN2022-11-19
16009880396693STIMPODXAVANT TECHNOLOGY (PTY) LTDBXN2022-11-19
06009880396689STIMPODXAVANT TECHNOLOGY (PTY) LTDBXN2022-11-18
06009880396788Xavant TechnologyXAVANT TECHNOLOGY (PTY) LTDBXN2021-08-18
16009880396785Xavant TechnologyXAVANT TECHNOLOGY (PTY) LTDBXN2021-08-18
04048223115770MULTISTIM VARIOPajunk GmbH MedizintechnologieBXN2021-07-13
04048223075920MULTISTIM SENSORPajunk GmbH MedizintechnologieBXN2021-04-02