KY® True Feel

GUDID 77067981993747

Personal 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
Primary Device ID77067981993747
NIH Device Record Keya3a02285-fc71-4469-a875-eb1131720493
Commercial Distribution Discontinuation2023-10-17
Commercial Distribution StatusNot in Commercial Distribution
Brand NameKY® True Feel
Version Model NumberPersonal Lubricant
Company DUNS081049410
Company NameRB Health (us) LLC
Device Count3
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1 (800) 756-5488
Emailxxx@xxx.xxx
Phone+1 (800) 756-5488
Emailxxx@xxx.xxx
Phone+1 (800) 756-5488
Emailxxx@xxx.xxx
Phone+1 (800) 756-5488
Emailxxx@xxx.xxx
Phone+1 (800) 756-5488
Emailxxx@xxx.xxx
Phone+1 (800) 756-5488
Emailxxx@xxx.xxx
Phone+1 (800) 756-5488
Emailxxx@xxx.xxx
Phone+1 (800) 756-5488
Emailxxx@xxx.xxx
Phone+1 (800) 756-5488
Emailxxx@xxx.xxx
Phone+1 (800) 756-5488
Emailxxx@xxx.xxx
Phone+1 (800) 756-5488
Emailxxx@xxx.xxx
Phone+1 (800) 756-5488
Emailxxx@xxx.xxx
Phone+1 (800) 756-5488
Emailxxx@xxx.xxx
Phone+1 (800) 756-5488
Emailxxx@xxx.xxx

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place away from direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place away from direct sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS140067981993743 [Unit of Use]
GS166067981993741 [Package]
Package: Case [4 Units]
Discontinued: 2023-10-17
Not in Commercial Distribution
GS177067981993747 [Package]
Contains: 88067981993743
Package: Carton [12 Units]
Discontinued: 2023-10-17
Not in Commercial Distribution
GS188067981993743 [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 Date2023-10-19
Device Publish Date2023-02-08

On-Brand Devices [KY® True Feel]

10067981993742Personal Lubricant
77067981993747Personal Lubricant

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