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
00850013816057
GS1

1
879057065 *Terms of Use
CHAMP 1 fl oz Water Based Bottle
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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
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FDA Product Code

[?]
Product Code Product Code Name
NUC Lubricant, Personal
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K051295 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

6a062a1b-d5b5-4423-8f2f-bbaf1e8a6d3d
May 02, 2023
1
April 24, 2023
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
7142599400
service@westridgelabs.com
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