myONE E55

GUDID 80726893510001

12 Lubricated Male Latex Condoms

GLOBAL PROTECTION CORP.

Basic male condom, Hevea-latex

• Primary Device ID: 80726893510001
• NIH Device Record Key: 6be0cc16-c1ef-400b-a22f-09968dc1ae95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: myONE E55
• Version Model Number: MYONE-E55-12
• Company DUNS: 364614362
• Company Name: GLOBAL PROTECTION CORP.
• Device Count: 12
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00726893510692 [Primary]
GS1	80726893510001 [Unit of Use]

FDA Product Code

• HIS: Condom

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-06-11
• Device Publish Date: 2020-06-03

On-Brand Devices [myONE E55]

• 80726893510001: 12 Lubricated Male Latex Condoms
• 00726893510005: 6 Lubricated Male Latex Condoms