DEVICE: KY Warming Jelly (00067981089486)
Device Identifier (DI) Information
KY Warming Jelly
Personal Lubricant
In Commercial Distribution
RECKITT BENCKISER LLC
Personal Lubricant
In Commercial Distribution
RECKITT BENCKISER LLC
Personal Lubricant
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No |
GMDN
[?]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
[?]Product Code | Product Code Name |
---|---|
NUC | Lubricant, personal |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store in a cool dry place away from direct sunlight |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
6af8e005-a0c1-46f1-9b51-48cc6d356503
March 29, 2018
2
September 20, 2016
March 29, 2018
2
September 20, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10067981089483 | 6 | 00067981089486 | In Commercial Distribution | Case | |
20067981089480 | 4 | 10067981089483 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)756-5488
xxx@xxx.xxx
xxx@xxx.xxx