KY Warming Jelly

GUDID 10067981993773

Lubricant

RB Health (us) LLC

Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant
Primary Device ID10067981993773
NIH Device Record Keyec2f36fb-81b6-4eb3-a3e0-8a54cd0c4251
Commercial Distribution StatusIn Commercial Distribution
Brand NameKY Warming Jelly
Version Model NumberPersonal Lubricant
Company DUNS081049410
Company NameRB Health (us) LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1 800-756-5488
Emailxxx@xxx.xxx
Phone1 800-756-5488
Emailxxx@xxx.xxx
Phone1 800-756-5488
Emailxxx@xxx.xxx
Phone1 800-756-5488
Emailxxx@xxx.xxx
Phone1 800-756-5488
Emailxxx@xxx.xxx
Phone1 800-756-5488
Emailxxx@xxx.xxx
Phone1 800-756-5488
Emailxxx@xxx.xxx
Phone1 800-756-5488
Emailxxx@xxx.xxx
Phone1 800-756-5488
Emailxxx@xxx.xxx
Phone1 800-756-5488
Emailxxx@xxx.xxx
Phone1 800-756-5488
Emailxxx@xxx.xxx
Phone1 800-756-5488
Emailxxx@xxx.xxx
Phone1 800-756-5488
Emailxxx@xxx.xxx
Phone1 800-756-5488
Emailxxx@xxx.xxx
Phone1 800-756-5488
Emailxxx@xxx.xxx
Phone1 800-756-5488
Emailxxx@xxx.xxx
Phone1 800-756-5488
Emailxxx@xxx.xxx

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of reach of children Slippery avoid spills Store in a cool dry place away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of reach of children Slippery avoid spills Store in a cool dry place away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of reach of children Slippery avoid spills Store in a cool dry place away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of reach of children Slippery avoid spills Store in a cool dry place away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of reach of children Slippery avoid spills Store in a cool dry place away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of reach of children Slippery avoid spills Store in a cool dry place away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of reach of children Slippery avoid spills Store in a cool dry place away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of reach of children Slippery avoid spills Store in a cool dry place away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of reach of children Slippery avoid spills Store in a cool dry place away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of reach of children Slippery avoid spills Store in a cool dry place away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of reach of children Slippery avoid spills Store in a cool dry place away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of reach of children Slippery avoid spills Store in a cool dry place away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of reach of children Slippery avoid spills Store in a cool dry place away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of reach of children Slippery avoid spills Store in a cool dry place away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of reach of children Slippery avoid spills Store in a cool dry place away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of reach of children Slippery avoid spills Store in a cool dry place away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of reach of children Slippery avoid spills Store in a cool dry place away from direct sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS100067981993776 [Package]
Contains: 99067981993770
Package: Carton [1 Units]
In Commercial Distribution
GS110067981993773 [Package]
Contains: 00067981993776
Package: Case [24 Units]
In Commercial Distribution
GS199067981993770 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NUCLubricant, Personal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-05
Device Publish Date2023-04-27

On-Brand Devices [KY Warming Jelly ]

10067981993773Lubricant
77067981993778Lubricant

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