FDA.reportPublic FDA data

BIOFILM, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20257712025771BIOFILM, INC.1N2026-01-013225 Executive Rdg VISTA CA US 92081
20257712025771BIOFILM, INC.1N2020-04-253225 Executive Rdg VISTA CA US 92081

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00015594000015Astroglide Sensual Strawberry Personal Lubricant - Astroglide Gel is a personal lubricant for penile and/or vaginal 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 and polyurethane condoms.1-800-431-2610sircmrof@combe.com
00015594000046Astroglide X Silicone Liquid - 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.1-800-431-2610sircmrof@combe.com
00015594011653Astroglide Organix Liquid - Astroglide® Organix Liquid Personal Lubricant is non-sterile, colorless to slight yellow, 95% organic and water-based personal lubricant. The glycerin and botanicals are certified USDA organic, helping to contribute to an NSF/ANSI 305 certified final product. This product is not a spermicide or contraceptive. Organix Liquid is compatible with natural rubber latex condoms. Organix Liquid is not compatible with polyurethane, or polyisoprene condoms.1-800-848-5900customer.service@biofilm.com
00015594011813Astroglide Ultra Gentle Gel - Astroglide Ultra Gentle Gel 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.1-800-848-5900customer.service@biofilm.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3226201144058058K935299ASTROGLIDEKMJ1994-02-18
468211589629306K935299ASTROGLIDEKMJ1994-02-18
3226201226965987K221036Astroglide WarmingNUC2022-07-01
3226201967592712K220653Astroglide Glycerin & Paraben FreeNUC2022-05-06
3226201884600624K220355Astroglide Ultra Gentle GelNUC2022-05-26
3226201567204752K213671Astroglide Sensual Strawberry Personal LubricantNUC2022-03-03
3226201362013653K210242Astroglide X Silicone Personal LubricantNUC2021-04-28
3226202021214033K200114Astroglide Organix LiquidNUC2020-10-13
3226201144081031K171985Astroglide O Oil Personal Lubricant & Massage OilNUC2017-08-30
468212028270355K171985Astroglide O Oil Personal Lubricant & Massage OilNUC2017-08-30
468211064605872K163395Astroglide Diamond Silicone Gel Personal LubricantNUC2017-02-10
3226201315781538K163395Astroglide Diamond Silicone Gel Personal LubricantNUC2017-02-10
468211072137794K141581ASTROGLIDE NATURALNUC2014-08-06
3226201406734962K141581ASTROGLIDE NATURALNUC2014-08-06
468211384216998K141132ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANTPEB2015-01-09
3226201351666814K140590ASTROGLIDE SENSUAL STRAWBERRYNUC2014-10-30
468211406407987K140590ASTROGLIDE SENSUAL STRAWBERRYNUC2014-10-30
3226201791135184K072647GLYCERIN & PARABEN FREE ASTROGLIDENUC2008-01-25
468212072521403K072647GLYCERIN & PARABEN FREE ASTROGLIDENUC2008-01-25
3226201757508041K041432ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANTHIS2004-11-30
468212022817848K041432ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANTHIS2004-11-30
468211117502759K003867EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET)NUC2001-03-09
3226201263232911K003867EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET)NUC2001-03-09

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NUC182022-07-01
HIS22004-11-30
KMJ21994-02-18
PEB12015-01-09

PMN#

GUDID#

Astroglide Organix Liquid - Astroglide® Organix Liquid Personal Lubricant is non-sterile, colorless to slight yellow, 95% organic and water-based personal lubricant. The glycerin and botanicals are certified USDA organic, helping to contribute to an NSF/ANSI 305 certified final product. This product is not a spermicide or contraceptive. Organix Liquid is compatible with natural rubber latex condoms. Organix Liquid is not compatible with polyurethane, or polyisoprene condoms.

BIOFILM, INC

2023-06-10

Astroglide Organix Liquid - Astroglide® Organix Liquid Personal Lubricant is non-sterile, colorless to slight yellow, 95% organic and water-based personal lubricant. The glycerin and botanicals are certified USDA organic, helping to contribute to an NSF/ANSI 305 certified final product. This product is not a spermicide or contraceptive. Organix Liquid is compatible with natural rubber latex condoms. Organix Liquid is not compatible with polyurethane, or polyisoprene condoms.

BIOFILM, INC

2022-02-15

Astroglide TTC - Trying to Conceive - Astroglide TTC is a personal lubricant for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. Astroglide TTC comes in 8 individually wrapped 5 mL pre-filled single use applicators. Astroglide TTC is compatible with sperm, oocytes, and embryos and can be used by couples trying to conceive. Astroglide TTC is compatible with natural rubber latex, polyisoprene and polyurethane condoms.

BIOFILM, INC

2016-09-13