FDA.reportPublic FDA data

AVANOS

Primary DI
00193494327897
Brand
AVANOS
Company
Avanos Medical, Inc.
Model
32789
Catalog number
RBW-5U
Device description
Universal Lead Set
Published
2020-05-08
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
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
00193494327897PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00193494327897001934943278971934943278970193494327897

GMDN Terms#

Term, Definition table
TermDefinition
Nerve-locating systemAn multicomponent assembly of electrically-powered devices designed to locate a nerve by applying an electrical stimulus with a probe and observing muscle responses. Once the pathways are located, their transmission capabilities can be assessed by comparing observed muscle responses with the expected maximum contractions. The system includes an electrical pulse generator, appropriate electrodes, sensors to detect muscle response (e.g., a strain gauge), and audible and/or visual indicators it does not display electromyography (EMG) readings. It is used during the diagnosis and assessment of nerve function and to locate nerves during surgery to reduce the incidence of accidental injury.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(844)428-2667PIQ@AVANOS.COM

Regulatory Flags#

DUNS number
079375431
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10680651458350Halyard4583525-0082017-09-18
10680651458367Halyard4583625-0102017-09-18
10680651458374Halyard4583725-0122017-09-18
10680651469035Halyard4690325-0142017-09-18
10680651469042Halyard4690425-0162017-09-18
10680651469059Halyard4690525-0182017-09-18
00193494135263AVANOS*500108750010872020-09-25
10680651124767COOLIEF* Cooled Radiofrequency QUICKCLAMP* Device12476SIA-QC2016-05-17
00812120005083Game Ready* 6' Dual Connector Hose, Rental120004997570302-RN2026-04-24
00812120005090Game Ready* 6' Medical Connector Hose, Rental120004999570304-RN2026-04-24
00812120005106Game Ready* Wrap Extender Strap Kit, Rental120004998573226-RN2026-04-17
00609038351117AVANOS35111351112020-04-01
00609038351124AVANOS35112351122020-04-01
00609038351131AVANOS35113351132020-04-01
00609038351148AVANOS35114351142020-04-01
00609038351155AVANOS35115351152020-04-01
00609038351162AVANOS35116351162020-04-01
00609038351179AVANOS35117351172020-04-01
00609038351186AVANOS35118351182020-04-01
00609038351193AVANOS35119351192020-04-01

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
04048223115787MULTISTIM VARIOPajunk GmbH MedizintechnologieBXN2021-07-13
04048223115770MULTISTIM VARIOPajunk GmbH MedizintechnologieBXN2021-07-13