FDA.reportPublic FDA data

One and FC2

Primary DI
00726893115804
Brand
One and FC2
Company
GLOBAL PROTECTION CORP.
Model
110100U-F
Device description
FC2@Home Mailer w/Move 7 Internal Condoms, 5 Move Sachets
Published
2023-12-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MBUSingle-Use Internal Condom
NUCLubricant, Personal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBUSingle-Use Internal CondomObstetrics/Gynecology2
NUCLubricant, PersonalObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00726893115804PrimaryGS10
80726893115800Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00726893115804007268931158047268931158040726893115804
8072689311580080726893115800

GMDN Terms#

Term, Definition table
TermDefinition
Female condom, synthetic polymerA sheath made of synthetic polymers (e.g., polyurethane or nitrile) with rings on either end that is inserted into the vagina before coitus to prevent sperm from gaining access to the female reproductive tract and/or to prevent the transmission of sexually transmitted infections (STI) between sexual partners. It typically includes a lubricant to minimize friction during coitus. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature in a dark, dry place. Avoid excessive heat.

Contacts#

Phone, Email table
PhoneEmail
6179462800ccataldo@globalprotection.com

Regulatory Flags#

DUNS number
364614362
Device count
12
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20726893120574One Super sensitive11600CY2026-04-28
20726893120673One Classic Select11000BYC2026-04-28
20726893120680One Classic Select11000BC2026-04-28
20726893120697One Flavorwaves110200BC2026-04-28
20726893120703One Legend11400BC2026-04-28
20726893120468One Ultra Feel112309C2026-04-24
20726893120475One Flex1131009C2026-04-24
20726893120499One Super Studs111709C2026-04-24
20726893120505One Vanish111309C2026-04-24
20726893120512One Pleasure Plus110309C2026-04-24
20726893120529One Super Sensitive11609C2026-04-24
20726893120536ONE Flavorwaves110209C2026-04-24
20726893120543One Legend11409C2026-04-24
20726893120550One Tattoo Touch112009C2026-04-24
20726893120567One Glowing Pleasures11509C2026-04-24
38858693803605AHF Impulse XL99AHF22C2026-04-24
38858693803612AHF Impulse99AHF20C2026-04-24
00726893120433One Extreme Ribs1125022026-04-24
00726893120440One Extreme Ribs1125092026-04-24
00726893120457One Flex113100B2026-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00796494455043LL Water-Based Gallon LubricantCC Wellness LLCNUC2026-05-28
08887500730017SuperSlydeICM PHARMA PTE. LTD.NUC2026-04-29
08887500730024SuperSlydeICM PHARMA PTE. LTD.NUC2026-04-29
08887500730031SuperSlydeICM PHARMA PTE. LTD.NUC2026-04-29
08859798108090LIFESTYLESSURETEX LIMITED - BRANCHNUC2026-01-27
20011509061328VagisilCombe IncorporatedNUC2026-01-26
00067981089127KY Personal Lubricant JellyRB Health (us) LLCNUC2025-12-09
00067981089486KY Warming Jelly RB Health (us) LLCNUC2025-12-09
00067981952292KY Intense Pleasure GelRB Health (us) LLCNUC2025-12-09
00067981993691KY Personal Lubricant JellyRB Health (us) LLCNUC2025-12-09
00067981993738KY Personal Lubricant JellyRB Health (us) LLCNUC2025-12-09
00067981993967KY Natural Feeling with Hyaluronic AcidRB Health (us) LLCNUC2025-12-09
00067981993974KY Natural Feeling with Hyaluronic AcidRB Health (us) LLCNUC2025-12-09
00067981993981KY Natural Feeling with Aloe Vera LubricantRB Health (us) LLCNUC2025-12-09
30726893210043One MoveGLOBAL PROTECTION CORP.NUC2025-11-13
00016169700057Nauox Yin YangMAYER LABORATORIES, INC.NUC2025-10-06
00016169700064Nauox Holy HoneyMAYER LABORATORIES, INC.NUC2025-10-06
00016169700071Nauox Dulce DreamsMAYER LABORATORIES, INC.NUC2025-10-06
00016169700088Nauox Sweet HavenMAYER LABORATORIES, INC.NUC2025-10-06
00016169700095Naoux Agave NectarMAYER LABORATORIES, INC.NUC2025-10-06
00016169700194Femme GlydeMAYER LABORATORIES, INC.NUC2025-10-06
00198715811087Kindra V LubeMAYER LABORATORIES, INC.NUC2025-10-06
07964944077692LubeLife - Water-based 8oz - Retail - 3pkCC Wellness LLCNUC2025-07-22
07964944078996LubeLife - Strawberry 8oz - Retail - 3pkCC Wellness LLCNUC2025-07-22
00067981993783K-Y® Hydrablend RB Health (us) LLCNUC2025-07-10
08032595872429REVAREEFARMA DERMA SRLNUC2025-06-26
08032595872436REVAREEFARMA DERMA SRLNUC2025-06-26
08859798106058LIFESTYLESSURETEX LIMITED - BRANCHNUC2025-06-18
00067981994155KY Warming Liquid LubricantRB Health (us) LLCNUC2025-06-01
00067981994162KY Yours & Mine Couples LubricantRB Health (us) LLCNUC2025-06-01