KY Extra Lubricated Condoms

GUDID 10679810871901

Condom

RB Health (us) LLC

Basic male condom, Hevea-latex

• Primary Device ID: 10679810871901
• NIH Device Record Key: d6497e0b-b6cc-43b3-809a-ca890b7b543f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KY Extra Lubricated Condoms
• Version Model Number: Condom
• Company DUNS: 081049410
• Company Name: RB Health (us) LLC
• Device Count: 48
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does n
• 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: +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 (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat

Device Identifiers

Device Issuing Agency	Device ID
GS1	00067981087192 [Primary]
GS1	10067981087199 [Unit of Use]
GS1	10679810871901 [Package]; Contains: 00067981087192; Package: Carton [9 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: 2
• Public Version Date: 2018-12-13
• Device Publish Date: 2018-10-31

On-Brand Devices [KY Extra Lubricated Condoms]

• 10679810871901: Condom
• 10679810871802: Condom
• 10679810871703: Condom
• 00067981087185: Condom
• 00067981087178: Condom
• 10067981087755: Condom
• 00067981087192: Condom