NOVEOS Wash Buffer Concentrate Pack

GUDID 00816879029512

HYCOR BIOMEDICAL LLC

Buffered wash solution IVD

• Primary Device ID: 00816879029512
• NIH Device Record Key: 18c36800-b890-497e-b365-4cccb37cf28b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NOVEOS Wash Buffer Concentrate Pack
• Version Model Number: 63165Z
• Company DUNS: 010558476
• Company Name: HYCOR BIOMEDICAL 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: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com
• Phone: 800-382-2527
• Email: Customerservices-us@hycorbiomedical.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816879029512 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182479

FDA Product Code

• DHB: System, Test, Radioallergosorbent (Rast) Immunological

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: 2025-05-20
• Device Publish Date: 2025-05-12

On-Brand Devices [NOVEOS Wash Buffer Concentrate Pack]

• 00816879023046: 63165
• 00816879029512: 63165Z