DEVICE: CHAMP 1 fl oz Water Based Bottle (00850013816057)
Device Identifier (DI) Information
CHAMP 1 fl oz Water Based Bottle
CHAMP 1 fl oz Water Based Bottle
In Commercial Distribution
IDD11394
WESTRIDGE LABORATORIES INCORPORATED
CHAMP 1 fl oz Water Based Bottle
In Commercial Distribution
IDD11394
WESTRIDGE LABORATORIES INCORPORATED
CHAMP 1 fl oz Water Based Bottle
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
60412 | Sexual lubricant |
A substance (e.g., a gel or jelly) intended to be applied to the penis, vagina and/or anus for lubrication during sexual intercourse or to be used with a sexual vibrator. This substance contains no pharmaceutical ingredients. After application, this device cannot be reused.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NUC | Lubricant, Personal |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K051295 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
6a062a1b-d5b5-4423-8f2f-bbaf1e8a6d3d
May 02, 2023
1
April 24, 2023
May 02, 2023
1
April 24, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
40850013816055 | 24 | 00850013816057 | In Commercial Distribution |
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
[?]
7142599400
service@westridgelabs.com
service@westridgelabs.com