AccessGUDID - DEVICE: Perifit (07109615470598)

GUDID

Device Identifier (DI) Information

Brand Name: Perifit
Version or Model: Pink Perifit
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: X6 INNOVATIONS

Primary DI Number: 07109615470598
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 264648644 *Terms of Use

Device Description: Perifit Kegel Exerciser with App

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):	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?
46624	Pelvic floor muscle exerciser	A manual device used by women to provide Kegel exercise (alternate contraction and relaxation of perineal muscles) to treat urinary stress incontinence, sexual dysfunction, or to tone the muscles of the pelvic floor. It is typically inserted into the vagina and is available in a variety of designs that commonly includes a spring-loaded, split, cantilevered cylinder that requires the voluntary contraction of the vagina to squeeze it together, or a solid metal, profiled weight that is gripped by the vaginal muscles as gravity pulls it downward. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KXQ	Vibrator For Therapeutic Use, Genital

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 43eeeaaf-824e-45c1-9ccb-bc3ada22bcf2
Public Version Date: May 04, 2023
Public Version Number: 2
DI Record Publish Date: June 15, 2021

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: Yes
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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