AccessGUDID - DEVICE: Leva Pelvic Health System (00860002994406)

GUDID

Device Identifier (DI) Information

Brand Name: Leva Pelvic Health System
Version or Model: Leva-02
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Axena Health, Inc.

Primary DI Number: 00860002994406
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118990269 *Terms of Use

Device Description: The Leva Pelvic Health System (“Leva PHS” or “Leva System”) is a prescription intra-vaginal device designed to allow the user to rehabilitate and strengthen their pelvic floor muscles (PFM) as well as allow them to monitor their progress during pelvic floor muscle training (PFMT). The Leva system is designed to wirelessly facilitate PFMT in women and to transmit real-time performance data through a dedicated mobile application that has been downloaded onto the patient’s mobile device. The Leva system is designed to be used vaginally and is intended to be used repeatedly by a single patient.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
32686	Perineometer	A device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The device measures the strength of the perineal muscles by offering resistance to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, urinary incontinence or sexual dysfunction.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HIR	Perineometer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K213913	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
Storage Environment Temperature: between 5 and 70 Degrees Celsius
Storage Environment Humidity: between 0 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: less than 70 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 03a5254a-f640-4100-b310-7eb2bf6368f5
Public Version Date: October 09, 2023
Public Version Number: 2
DI Record Publish Date: April 27, 2020