AccessGUDID - DEVICE: KY UltraGel Personal Lubricant (00067981087352)

GUDID

Device Identifier (DI) Information

Brand Name: KY UltraGel Personal Lubricant
Version or Model: Personal Lubricant
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: RB Health (us) LLC

Primary DI Number: 00067981087352
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081049410 *Terms of Use

Device Description: Personal Lubricant

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?
34131	Vaginal lubricant	A non-sterile substance (e.g., a gel or jelly) designed to lubricate the vagina to facilitate entry of a gloved finger(s) or a device, e.g., a vaginal speculum, during a diagnostic or therapeutic treatment. This substance will be compatible to the sensitive mucous and tissue of this area. 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 [?]
K020827	000
K192982	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
Special Storage Condition, Specify: Store below 77° F (25° C)

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a33143b5-6427-4d04-a10a-efbbe8d6a5d9
Public Version Date: April 05, 2022
Public Version Number: 6
DI Record Publish Date: September 20, 2016