AccessGUDID - DEVICE: Kimono Swirl (00016169541056)

GUDID

Device Identifier (DI) Information

Brand Name: Kimono Swirl
Version or Model: Swirl Silcone Lubricant
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 54105
Company Name: MAYER LABORATORIES, INC.

Primary DI Number: 00016169541056
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 175425982 *Terms of Use

Device Description: Personal Lubricant - Silicone 2 ml

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):	Yes
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?
60412	Sexual lubricant	A substance (e.g., a gel or jelly) intended to be applied to the penis, vagina and/or anus for lubrication during sexual intercourse or to be used with a sexual vibrator. This substance contains no pharmaceutical ingredients. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NUC	Lubricant, personal

FDA Premarket Submission

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

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
Special Storage Condition, Specify: NO DIRECT SUNLIGHT OR HEAT
Storage Environment Temperature: between 40 and 90 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 2 Milliliter

Device Record Status

Public Device Record Key: fd5a8fe3-1e8f-439b-8795-80d8ddb846b7
Public Version Date: November 13, 2023
Public Version Number: 1
DI Record Publish Date: November 03, 2023