AccessGUDID - DEVICE: Vibrant Pod (00860009189812)

GUDID

Device Identifier (DI) Information

Brand Name: Vibrant Pod
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VIBRANT LTD

Primary DI Number: 00860009189812
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 532222218 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
66618	Internal gastrointestinal vibratory-stimulation system activation unit	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QTN	Orally Ingested Transient Device For Constipation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN210052	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 88d69560-c2bb-4392-be5e-876455f66f40
Public Version Date: December 23, 2022
Public Version Number: 1
DI Record Publish Date: December 15, 2022