GiCalm

Primary DI
08908006064229
Brand
GiCalm
Company
NEUROSTIMULATION MEDTECH PRIVATE LIMITED
Model
GiCalm
Device description
GiCalm
Published
2026-03-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QHHNon-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QHHNon-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08908006064229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08908006064229089080060642298908006064229

GMDN Terms#

Term, Definition table
TermDefinition
Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulatorA body-worn, electronic device intended to provide percutaneous electrical nerve field stimulation (PENFS) applied close to cranial/peripheral nerves around the external ear to achieve remote symptom relief mediated by central nervous system (CNS) pathways and structures [e.g., amygdala, spinal cord neurons]; depending on the treatment protocol and device settings it may be used for opioid withdrawal symptoms (e.g., bone/joint aches, tremor, anxiety), or irritable bowel syndrome [IBS]-associated functional abdominal pain (FAP). It consists of an electrical pulse generator with minimally-invasive electrodes, and accessories (e.g., adhesives, transilluminator). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
916731981
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08908006064311Morph DeviceMorph Device2026-05-22
08908006064328POSP DevicePOSP Device2026-05-22
08908006064199Primary Relief Primary Relief 2026-03-16
08908006064205OpiEaseOpiEase2026-03-16
08908006064212NociRelief NociRelief 2026-03-16
08908006064236NS100NS1002026-03-16
08908006064243First Relief v1First Relief v12026-03-16
08908006064267ANSiSTIM - PP ANSiSTIM - PP 2026-03-16
08908006064281ANSiSTIM-PP ANSiSTIM-PP 2026-03-16
08908006064250NEUMONANEUMONA2025-08-18
08908006064168POSP Device POSP Device 2025-05-19
08908006064090NeuroSolutions 100NeuroSolutions 1002024-07-19
08908006064106OpiReliefOpiRelief2024-07-19
08908006064113Morph DeviceMorph Device2024-07-20
08908006064120S.T. GenesisS.T. Genesis2024-07-20
08908006064083Drug Relief v1Drug Relief v12026-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08908006064243First Relief v1NEUROSTIMULATION MEDTECH PRIVATE LIMITEDQHH2026-03-16
B960NSS203NSS IB-STIMNeuraxis, Inc.QHH2020-11-09
B960NSS2031NSS IB-STIMInnovative Health Solutions, IncQHH2020-11-09
B327NSS203IB-STIMKEY ELECTRONICS, INC.QHH2019-09-18
B327NSS2032IB-STIMKEY ELECTRONICS, INC.QHH2019-09-18