AccessGUDID - DEVICE: Vivally (00860009634046)

GUDID

Device Identifier (DI) Information

Brand Name: Vivally
Version or Model: VPG-KTS01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Avation Medical, Inc.

Primary DI Number: 00860009634046
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081061890 *Terms of Use

Device Description: No description.

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):	Yes
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?
65016	Transcutaneous incontinence-control electrical stimulator	A device or device assembly available for use by a patient/layperson outside a clinical setting (e.g., in the home) designed to treat urinary and/or faecal incontinence through the transcutaneous (noninvasive) application of electrical stimuli to the muscles of the pelvic floor to induce Kegel-like contractions. It consists of an electrically-powered external pulse generator/biofeedback unit with controls (e.g., wearable remote control) intended for wired or wireless connection to a skin gel pad with surface electrodes designed to be placed on the pubic area; the gel pad may be included in the device assembly. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NAM	Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K220454	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: 785d1184-e6bf-43b3-8d9a-b59e73ed667f
Public Version Date: August 09, 2023
Public Version Number: 1
DI Record Publish Date: August 01, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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