DUREX Play Ring of Bliss Vibrating Ring and 1 Nat

GUDID 10302340853788

Condom

RB Health (us) LLC

Basic male condom, Hevea-latex

• Primary Device ID: 10302340853788
• NIH Device Record Key: 6ba9f269-a0c8-4956-98db-e1f32f3db161
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUREX Play Ring of Bliss Vibrating Ring and 1 Nat
• Version Model Number: Condom and General product
• Company DUNS: 081049410
• Company Name: RB Health (us) LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does n
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• 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: +1(800)756-5488
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place away from direct sunlight. Avoid excess heat, store in a cool dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00302340853781 [Primary]
GS1	10302340853788 [Package]; Contains: 00302340853781; Package: Case [6 Units]; In Commercial Distribution
GS1	20302340853785 [Package]; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980319

FDA Product Code

• HIS: CONDOM

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-13
• Device Publish Date: 2017-08-31

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