ONE Flex

GUDID 20726893118113

Latex lubricated condoms

GLOBAL PROTECTION CORP.

Basic male condom, Hevea-latex
Primary Device ID20726893118113
NIH Device Record Keya3505974-fa12-4671-82de-d5c929cf26a2
Commercial Distribution StatusIn Commercial Distribution
Brand NameONE Flex
Version Model Number11P31B10K
Company DUNS364614362
Company NameGLOBAL PROTECTION CORP.
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone6179462800
Emailccataldo@globalprotection.com
Phone6179462800
Emailccataldo@globalprotection.com
Phone6179462800
Emailccataldo@globalprotection.com
Phone6179462800
Emailccataldo@globalprotection.com
Phone6179462800
Emailccataldo@globalprotection.com
Phone6179462800
Emailccataldo@globalprotection.com
Phone6179462800
Emailccataldo@globalprotection.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature in a dark, dry place. Avoid excessive heat.

Device Identifiers

Device Issuing AgencyDevice ID
GS100726893118119 [Primary]
GS120726893118113 [Package]
Contains: 00726893118119
Package: case of 18 [18 Units]
In Commercial Distribution
GS180726893118115 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HISCondom

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-15
Device Publish Date2024-04-05

On-Brand Devices [ONE Flex]

10726893115139one flex- Latex Lubricated Condoms
80726893115121Lubricated Latex condoms, Case of 36 (6 Bundles of 6)
20726893118113Latex lubricated condoms
80726893118337Latex Condoms

Trademark Results [ONE Flex]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ONE FLEX
ONE FLEX
98063624 not registered Live/Pending
Global Protection Corp.
2023-06-28

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