AccessGUDID - DEVICE: Fuckwater - Original Water Based Lubricant - 8oz (00796494002469)

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Device Identifier (DI) Information

Brand Name: Fuckwater - Original Water Based Lubricant - 8oz
Version or Model: 71202
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: CC Wellness LLC

Primary DI Number: 00796494002469
Issuing Agency: GS1
Commercial Distribution End Date: November 15, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 067692292 *Terms of Use

Device Description: Water-Based Personal Lubricant

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Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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 [?]
K171730	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: 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

Public Device Record Key: 19fa495c-86e2-4b44-84b9-887cd7ca0c3e
Public Version Date: November 16, 2023
Public Version Number: 2
DI Record Publish Date: May 17, 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
10796494002466	12	00796494002469	2023-11-15	Not 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)

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
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Production Identifier(s) in UDI

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

No Customer Contact currently defined

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