Vibrant Starter Kit

Primary DI
00860009189829
Brand
Vibrant Starter Kit
Company
VIBRANT LTD
Model
1
Device description
The starter kit contains a Pod (with USB cable and AC/DC USB adaptor) and 2 blisters of capsules: 10 capsules/ blister (total of 20 capsules).
Published
2022-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

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
00860009189829PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009189829008600091898298600091898290860009189829

GMDN Terms#

Term, Definition table
TermDefinition
Internal gastrointestinal vibratory-stimulation systemAn assembly of electrically-powered devices intended to apply mechanical vibrations to the gastrointestinal (GI) tract internally to stimulate peristalsis and bowel evacuation (e.g., to treat constipation). It consists of a disposable, ingestible vibrating capsule intended to be introduced into, and stimulate, the (GI) tract, and a capsule activation unit designed to activate the capsule with the required vibration protocol (vibration duration and resting stages) prior to swallowing. Typically considered a complimentary therapy device, it is intended for use in both the home and clinical setting.

Storage And Handling#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
0086000918980520 Vibrant capsules12022-12-15
00860009189812Vibrant Pod12022-12-15