ONE Flex

GUDID 20726893118113

Latex lubricated condoms

GLOBAL PROTECTION CORP.

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• Primary Device ID: 20726893118113
• NIH Device Record Key: a3505974-fa12-4671-82de-d5c929cf26a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ONE Flex
• Version Model Number: 11P31B10K
• Company DUNS: 364614362
• Company Name: GLOBAL PROTECTION CORP.
• Device Count: 10
• 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

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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00726893118119 [Primary]
GS1	20726893118113 [Package]; Contains: 00726893118119; Package: case of 18 [18 Units]; In Commercial Distribution
GS1	80726893118115 [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: 2024-04-15
• Device Publish Date: 2024-04-05

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