b condoms

GUDID 00850281004309

For Contraception Plus STI Protection

B HOLDING GROUP LLC

Basic male condom, Hevea-latex

• Primary Device ID: 00850281004309
• NIH Device Record Key: ff2f3fc4-9783-422f-9348-707d74ccb62e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: b condoms
• Version Model Number: Fitted b condoms
• Company DUNS: 006108561
• Company Name: B HOLDING GROUP LLC
• Device Count: 1000
• 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: 646-397-0460
• Email: info@bholdinggroup.com
• Phone: 646-397-0460
• Email: info@bholdinggroup.com
• Phone: 646-397-0460
• Email: info@bholdinggroup.com
• Phone: 646-397-0460
• Email: info@bholdinggroup.com
• Phone: 646-397-0460
• Email: info@bholdinggroup.com
• Phone: 646-397-0460
• Email: info@bholdinggroup.com
• Phone: 646-397-0460
• Email: info@bholdinggroup.com
• Phone: 646-397-0460
• Email: info@bholdinggroup.com
• Phone: 646-397-0460
• Email: info@bholdinggroup.com
• Phone: 646-397-0460
• Email: info@bholdinggroup.com
• Phone: 646-397-0460
• Email: info@bholdinggroup.com
• Phone: 646-397-0460
• Email: info@bholdinggroup.com
• Phone: 646-397-0460
• Email: info@bholdinggroup.com
• Phone: 646-397-0460
• Email: info@bholdinggroup.com
• Phone: 646-397-0460
• Email: info@bholdinggroup.com
• Phone: 646-397-0460
• Email: info@bholdinggroup.com
• Phone: 646-397-0460
• Email: info@bholdinggroup.com
• Phone: 646-397-0460
• Email: info@bholdinggroup.com
• Phone: 646-397-0460
• Email: info@bholdinggroup.com
• Phone: 646-397-0460
• Email: info@bholdinggroup.com
• Phone: 646-397-0460
• Email: info@bholdinggroup.com
• Phone: 646-397-0460
• Email: info@bholdinggroup.com
• Phone: 646-397-0460
• Email: info@bholdinggroup.com
• Phone: 646-397-0460
• Email: info@bholdinggroup.com
• Phone: 646-397-0460
• Email: info@bholdinggroup.com
• Phone: 646-397-0460
• Email: info@bholdinggroup.com
• Phone: 646-397-0460
• Email: info@bholdinggroup.com
• Phone: 646-397-0460
• Email: info@bholdinggroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850281004309 [Unit of Use]
GS1	10850281004306 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K994095

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: 2020-09-09
• Device Publish Date: 2020-09-01

On-Brand Devices [b condoms]

• 10850281004313: For Contraception Plus STI Protection
• 00850281004019: For Contraception Plus STI Protection
• 00850281004002: For Contraception Plus STI Protection
• 00850281004477: For Contraception Plus STI Protection
• 00850281004408: For Contraception Plus STI Protection
• 00850281004392: For Contraception Plus STI Protection
• 00850281004361: For Contraception Plus STI Protection
• 00850281004347: For Contraception Plus STI Protection
• 00850281004309: For Contraception Plus STI Protection
• 00850281004415: For Contraception Plus STI Protection
• 00850281004385: For Contraception Plus STI Protection
• 00850281004378: For Contraception Plus STI Protection
• 00850281004446: For Contraception Plus STI Protection
• 00850281004354: For Contraception Plus STI Protection
• 00850281004323: For Contraception Plus STI Protection
• 00850281004330: For Contraception Plus STI Protection
• 00850281004460: For Contraception Plus STI Protection
• 00850281004453: For Contraception Plus STI Protection
• 00850281004156: For Contraception Plus STI Protection
• 00850281004187: For Contraception Plus STI Protection
• 00850281004095: For Contraception Plus STI Protection
• 00850281004088: For Contraception Plus STI Protection