One

GUDID 20726893116898

ONE Flex USA 36-count

GLOBAL PROTECTION CORP.

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• Primary Device ID: 20726893116898
• NIH Device Record Key: 946779c3-4a98-4083-bcd7-6e6eb756b95c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: One
• Version Model Number: 1131009
• Company DUNS: 364614362
• Company Name: GLOBAL PROTECTION CORP.
• Device Count: 36
• 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

Customer Support Contacts

• Phone: 6179462800
• Email: ccataldo@globalprotection.com
• Phone: 6179462800
• Email: ccataldo@globalprotection.com
• Phone: 6179462800
• Email: ccataldo@globalprotection.com
• Phone: 6179462800
• Email: ccataldo@globalprotection.com
• Phone: 6179462800
• Email: ccataldo@globalprotection.com
• Phone: 6179462800
• Email: ccataldo@globalprotection.com
• Phone: 6179462800
• Email: ccataldo@globalprotection.com
• Phone: 6179462800
• Email: ccataldo@globalprotection.com
• Phone: 6179462800
• Email: ccataldo@globalprotection.com
• Phone: 6179462800
• Email: ccataldo@globalprotection.com
• Phone: 6179462800
• Email: ccataldo@globalprotection.com
• Phone: 6179462800
• Email: ccataldo@globalprotection.com
• Phone: 6179462800
• Email: ccataldo@globalprotection.com
• Phone: 6179462800
• Email: ccataldo@globalprotection.com
• Phone: 6179462800
• Email: ccataldo@globalprotection.com
• Phone: 6179462800
• Email: ccataldo@globalprotection.com
• Phone: 6179462800
• Email: ccataldo@globalprotection.com

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.
• 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	00726893116894 [Primary]
GS1	20726893116898 [Package]; Contains: 00726893116894; Package: Case of 24 [24 Units]; In Commercial Distribution
GS1	80726893116890 [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: 2024-02-14
• Device Publish Date: 2024-02-06

On-Brand Devices [One]

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