Vibrant Pod

Primary DI
00860009189812
Brand
Vibrant Pod
Company
VIBRANT LTD
Model
1
Device description
The Pod is a reusable Capsule activation unit. Patients use the Pod to activate Capsules at home. USB cable and AC/DC USB adaptor provided with the Pod.
Published
2022-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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
00860009189812PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009189812008600091898128600091898120860009189812

GMDN Terms#

Term, Definition table
TermDefinition
Internal gastrointestinal vibratory-stimulation system activation unitA noninvasive, electrically-powered component of an internal gastrointestinal vibratory-stimulation system intended to activate an ingestible capsule (not included) prior to swallowing. Typically a small portable unit, it is intended to transmit a pre-programmed vibration protocol (vibration duration and resting stages) to the capsule but is not intended to modify the protocol parameters (i.e., not a programmer). Typically considered a complimentary therapy device, it is intended for use in both the home and clinical setting. This is a reusable device.

Regulatory Flags#

DUNS number
532222218
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
0086000918980520 Vibrant capsules12022-12-15
00860009189829Vibrant Starter Kit12022-12-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
0086000918980520 Vibrant capsulesVIBRANT LTDQTN2022-12-15