FDA.reportPublic FDA data

STIMPOD

Primary DI
06009880396177
Brand
STIMPOD
Company
XAVANT TECHNOLOGY (PTY) LTD
Model
NMT Monitoring Cable EMG (3.0m)
Catalog number
XT-45003B
Device description
Neuromuscular blocking agent monitoring cable (3.0m) using electromyography. Accessory to be used with the STIMPOD NMS450 Nerve Stimulator.
Published
2024-11-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
BXNStimulator, Nerve, Battery-Powered

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213049000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213049000STIMPOD NMS450 Nerve StimulatorXavant Technology (Pty), Ltd.2022-10-16BXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06009880396177PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06009880396177060098803961776009880396177

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic peripheral nerve electrical stimulation systemAn assembly of devices designed to apply electrical stimuli in one peripheral region of the body while the response is monitored in another peripheral region. It typically consists of external electrodes (e.g., hand-held bipolar or ring electrodes) or needle electrodes and a pulse generator. It is used for the stimulation of a peripheral nerve or muscle in motor-nerve conduction studies (e.g., the posterior tibial nerve), and/or in sensory-nerve conduction studies (e.g., the ulnar nerve) performed during clinical electrophysiology (EP) assessments.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity00
Storage Environment Temperature00

Regulatory Flags#

DUNS number
639571707
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06009880396139Xavant TechnologySTIMPOD NMS450 KITXT-450112016-12-07
06009880396146Xavant TechnologySTIMPOD NMS450 Kit (3.5m)XT-45011A2017-01-10
06009880396153Xavant TechnologyNMBA Cable with accelerometer (1.5m)XT-450152017-04-06
06009880396313Xavant TechnologySTIMPOD NMS450 KitXT-450212018-01-30
06009880396320Xavant TechnologySTIMPOD NMS450 Kit (3.5m)XT-45021A2018-01-30
06009880396337Xavant TechnologyNMBA Cable with Accelerometer (1.8m)XT-450252018-01-30
06009880396344Xavant TechnologyNMBA Cable with Accelerometer (3.5m)XT-45025A2018-01-30
06009880396368Xavant TechnologySTIMPOD NMS410 KitXT-410112018-11-02
06009880396788Xavant TechnologySTIMPOD NMS450 AMG Only Kit (1.8m)XT-45021D2021-08-18
06009880396870STIMPODSTIMPOD NMS450X+XT-450302023-12-23
06009880396030Xavant TechnologyNerve mapping cableXT-460032017-07-18
06009880396078Xavant TechnologySTIMPOD NMS410 KitXT-410012017-06-13
06009880396160Xavant TechnologyNMBA Cable with accelerometer (3.5m)XT-45015A2017-01-10
06009880396085Xavant TechnologyNerve Locate CableXT-410032017-01-25
06009880396245Xavant TechnologySTIMPOD NMS460 KITXT-460012017-03-23
06009880396825Xavant TechnologySTIMPOD NMS460XT-46000A2023-11-11
06009880396832Xavant TechnologySTIMPOD NMS460 KitXT-46001A2023-06-02
06009880396184BIONESSSTIMPOD ST2-3000 KITST2-30002025-02-17
06009880396443BIOVENTUSSTIMPOD ST2-4010ST2-40102025-07-30
06009880396610STIMPOD X-LINKXT-45300XT-453002025-07-30

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
06009880396429STIMPODXAVANT TECHNOLOGY (PTY) LTDBXN2024-11-15
06009880396870STIMPODXAVANT 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
04048223115787MULTISTIM VARIOPajunk GmbH MedizintechnologieBXN2021-07-13
04048223115770MULTISTIM VARIOPajunk GmbH MedizintechnologieBXN2021-07-13
04048223075920MULTISTIM SENSORPajunk GmbH MedizintechnologieBXN2021-04-02