KY Warming Jelly

GUDID 77067981993778

Lubricant

RB Health (us) LLC

Vaginal lubricant
Primary Device ID77067981993778
NIH Device Record Keyec2f36fb-81b6-4eb3-a3e0-8a54cd0c4251
Commercial Distribution Discontinuation2023-12-05
Commercial Distribution StatusNot in 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
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
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
GS177067981993778 [Package]
Contains: 88067981993774
Package: Case [24 Units]
Discontinued: 2023-12-05
Not in Commercial Distribution
GS188067981993774 [Package]
Contains: 99067981993770
Package: Carton [1 Units]
Discontinued: 2023-12-05
Not 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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-12-07
Device Publish Date2023-04-27

On-Brand Devices [KY Warming Jelly ]

10067981993773Lubricant
77067981993778Lubricant

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