One and FC2

Primary DI
80726893115800
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
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MBUSingle-Use Internal Condom

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBUSingle-Use Internal CondomObstetrics/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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6179462800ccataldo@globalprotection.com

Regulatory Flags#

DUNS number
364614362
Device count
12
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00726893120365One Lux11320062026-06-08
00726893120594Harmony Latex DamPHA202R2026-06-08
00726893120600harmony Non- Latex damsPHA101U2026-06-08
00726893120617Harmony Latex DamsPHA202U2026-06-08
00726893120730One Lux11330062026-06-08
00726893120747One Lux11340062026-06-08
00726893120778One Unity Collection11600BY2026-06-08
00726893120945One Lux113200B2026-06-08
00726893120952One Lux113300B2026-06-08
00726893120969One Lux113400B2026-06-08
00810124865085Adam and Eve hard rider99PHE200C2026-06-08
00860015576620Swoon Ultra Thin99SWON2022026-06-08
10860015576603Swoon Ultra Thin99SWON200C2026-06-08
00726893120587Harmony non-Latex DamPHA101R2026-06-04
00726893120754TrustexTXD05U2026-06-04
00726893120761Super sensitiveCRDF-62026-06-04
20726893120482Mixed Pleasure110109C2026-06-04
20726893120710Glowing Pleasures11500BC2026-06-04
20726893120574One Super sensitive11600CY2026-04-28
20726893120673One Classic Select11000BYC2026-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00726893115804One and FC2GLOBAL PROTECTION CORP.MBU2023-12-04
00861783000126FC2 Female Condom®Veru Inc.MBU2021-05-11
00861783000102FC2 Female Condom®Veru Inc.MBU2021-05-11
30861783000103FC2Veru Inc.MBU2016-09-21
00861783000119FC2Veru Inc.MBU2016-09-21
40861783000100FC2Female Health CompanyMBU2016-09-21
10861783000116FC2Female Health CompanyMBU2016-09-21