One

GUDID 80726893115787

ONE@Home Standard Condom Mailer w/Non-Latex 20 condoms & 10 lube sachets

GLOBAL PROTECTION CORP.

Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex Basic male condom, Hevea-latex
Primary Device ID80726893115787
NIH Device Record Key01e99f4b-ee97-40ab-b80a-66d17ee50507
Commercial Distribution StatusIn Commercial Distribution
Brand NameOne
Version Model Number110100U-C
Company DUNS364614362
Company NameGLOBAL PROTECTION CORP.
Device Count30
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
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
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.
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.
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
GS100726893115781 [Primary]
GS180726893115787 [Unit of Use]

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 Date2023-12-12
Device Publish Date2023-12-04

On-Brand Devices [One]

80726893115756ONE@Home Standard Condom Mailer 20 condoms & 10 lube sachets ONE Super Sensitive
80726893115749ONE@Home XL Condom Mailer 20 condoms & 10 lube sachets ONE Move -ONE L
20726893114924ONE Pride Kit- Includes 6 assorted ONE lubricated latex condoms, 3 MOVE Lube Packets, Condom Pri
80726893115794ONE@Home Non-Latex Mailer w/Move 20 condoms & 10 Lube Sachets
80726893115787ONE@Home Standard Condom Mailer w/Non-Latex 20 condoms & 10 lube sachets
20726893116898ONE Flex USA 36-count

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