20 Vibrant capsules

Primary DI
00860009189805
Brand
20 Vibrant capsules
Company
VIBRANT LTD
Model
1
Device description
The Vibrant Capsule is a small dimension, easy to swallow capsule, bearing pre-programed stimulations specifically designed for individuals with chronic constipation. Each box contains 2 blisters with capsules. Each blister contains 10 capsules.
Published
2022-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
QTNOrally Ingested Transient Device For Constipation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QTNOrally Ingested Transient Device For ConstipationGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN210052000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN210052000Vibrant SystemVibrant, Ltd.2022-08-26QTN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009189805PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009189805008600091898058600091898050860009189805

GMDN Terms#

Term, Definition table
TermDefinition
Internal gastrointestinal vibratory-stimulation system capsuleA small, battery-powered, ingestible component of an internal gastrointestinal vibratory-stimulation system intended to be introduced into the gastrointestinal (GI) tract via the oral cavity to produce mechanical vibrations for stimulation of peristalsis and bowel evacuation (e.g., to treat constipation). It is in the form of a capsule that incorporates an electromechanical motor and processor. Typically considered a complimentary therapy device, it is intended for use in both the home and clinical setting. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
532222218
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009189812Vibrant Pod12022-12-15
00860009189829Vibrant Starter Kit12022-12-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009189812Vibrant PodVIBRANT LTDQTN2022-12-15