AccessGUDID - DEVICE: KY Warming Jelly (00067981089486)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 00067981089486
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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
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.

FDA Product Code

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Product Code	Product Code Name
NUC	Lubricant, personal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K040164	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 in a cool dry place away from direct sunlight

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6af8e005-a0c1-46f1-9b51-48cc6d356503
Public Version Date: December 13, 2018
Public Version Number: 4
DI Record Publish Date: September 20, 2016