K-Y® Hydrablend

GUDID 10067981993780

1.5 oz. KY Hydrablend Hybrid Personal Lubricant

RB Health (us) LLC

Vaginal lubricant

• Primary Device ID: 10067981993780
• NIH Device Record Key: 89f11f35-c46c-45e6-81ca-b24797daebaf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K-Y® Hydrablend
• Version Model Number: 00067981993783
• Company DUNS: 081049410
• Company Name: RB Health (us) LLC
• Device Count: 1
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00067981993783 [Primary]
GS1	10067981993780 [Package]; Contains: 00067981993783; Package: Case [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223519

FDA Product Code

• NUC: Lubricant, Personal

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: 2025-07-18
• Device Publish Date: 2025-07-10

On-Brand Devices [K-Y® Hydrablend ]

• 00067981993790: 4.5 oz. KY Hydrablend Hybrid Personal Lubricant
• 10067981993780: 1.5 oz. KY Hydrablend Hybrid Personal Lubricant