One Flex

GUDID 80726893118337

Latex Condoms

GLOBAL PROTECTION CORP.

Basic male condom, Hevea-latex

• Primary Device ID: 80726893118337
• NIH Device Record Key: 47d36dc8-f78b-41a0-9cce-b4e2394f8b6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: One Flex
• Version Model Number: 113100C-BULK
• Company DUNS: 364614362
• Company Name: GLOBAL PROTECTION CORP.
• Device Count: 3000
• DM Exempt: false
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	30726893118332 [Primary]
GS1	80726893118337 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203536

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: 2024-09-11
• Device Publish Date: 2024-09-03

On-Brand Devices [One Flex]

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