AccessGUDID - DEVICE: Astroglide X Silicone Liquid (00015594011837)

GUDID

Device Identifier (DI) Information

Brand Name: Astroglide X Silicone Liquid
Version or Model: 015594011837
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N/A
Company Name: BIOFILM, INC

Primary DI Number: 00015594011837
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790780258 *Terms of Use

Device Description: Astroglide® X Silicone Personal Lubricant is a personal lubricant for penile, vaginal, and/or anal application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyisoprene and polyurethane condoms.

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	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 [?]
K210242	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

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 70 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 2.5 Milliliter

Device Record Status

Public Device Record Key: f16c5665-d4bf-4d59-aba6-202b13d1087b
Public Version Date: June 19, 2023
Public Version Number: 1
DI Record Publish Date: June 10, 2023