GiCalm

GUDID 08908006064229

GiCalm

DYANSYS INDIA PRIVATE LIMITED

Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator

• Primary Device ID: 08908006064229
• NIH Device Record Key: dc87c359-79f8-4e1d-8fcf-f01cdbdc005c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GiCalm
• Version Model Number: GiCalm
• Company DUNS: 916731981
• Company Name: DYANSYS INDIA PRIVATE LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08908006064229 [Primary]

FDA Product Code

• QHH: Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-24
• Device Publish Date: 2026-03-16

Devices Manufactured by DYANSYS INDIA PRIVATE LIMITED

• 08908006064083 - Drug Relief v1: 2026-03-24 Drug Relief v1
• 08908006064199 - Primary Relief: 2026-03-24 Primary Relief
• 08908006064205 - OpiEase: 2026-03-24 OpiEase
• 08908006064212 - NociRelief: 2026-03-24 NociRelief
• 08908006064229 - GiCalm: 2026-03-24GiCalm
• 08908006064229 - GiCalm: 2026-03-24 GiCalm
• 08908006064236 - NS100: 2026-03-24 NS100
• 08908006064243 - First Relief v1: 2026-03-24 First Relief v1
• 08908006064267 - ANSiSTIM - PP: 2026-03-24 ANSiSTIM - PP