KidneyIntelX Blood Collection Convenience Kit

GUDID 00860009877900

Collection convenience kit used to collect, contain and ship human blood to a Renalytix clinical laboratory for KidneyIntelX testing.

Renalytix Ai, Inc.

General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit

• Primary Device ID: 00860009877900
• NIH Device Record Key: 57aa23a2-7162-4808-9611-2dd2b2a28d91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KidneyIntelX Blood Collection Convenience Kit
• Version Model Number: RENX-3011000
• Company DUNS: 117063935
• Company Name: Renalytix Ai, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: 888-203-2725
• Email: ClientServices@renalytix.com
• Phone: 888-203-2725
• Email: ClientServices@renalytix.com
• Phone: 888-203-2725
• Email: ClientServices@renalytix.com
• Phone: 888-203-2725
• Email: ClientServices@renalytix.com
• Phone: 888-203-2725
• Email: ClientServices@renalytix.com
• Phone: 888-203-2725
• Email: ClientServices@renalytix.com
• Phone: 888-203-2725
• Email: ClientServices@renalytix.com
• Phone: 888-203-2725
• Email: ClientServices@renalytix.com
• Phone: 888-203-2725
• Email: ClientServices@renalytix.com
• Phone: 888-203-2725
• Email: ClientServices@renalytix.com
• Phone: 888-203-2725
• Email: ClientServices@renalytix.com
• Phone: 888-203-2725
• Email: ClientServices@renalytix.com
• Phone: 888-203-2725
• Email: ClientServices@renalytix.com
• Phone: 888-203-2725
• Email: ClientServices@renalytix.com
• Phone: 888-203-2725
• Email: ClientServices@renalytix.com
• Phone: 888-203-2725
• Email: ClientServices@renalytix.com
• Phone: 888-203-2725
• Email: ClientServices@renalytix.com
• Phone: 888-203-2725
• Email: ClientServices@renalytix.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 36 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 36 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860009877900 [Primary]

FDA Product Code

• PQD: Blood Specimen Collection Convenience Kit (Excludes Hiv)

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: 2024-04-09
• Device Publish Date: 2022-03-25

On-Brand Devices [KidneyIntelX Blood Collection Convenience Kit]

• G229RENX301100021: Whole blood collection convenience kit for KidneyIntelX
• G229RENX30110001: Whole blood collection convenience kit for KidneyIntelX
• 00196852040506: Collection convenience kit used to collect, contain and ship human blood to a Renalytix clinical
• 00860009877900: Collection convenience kit used to collect, contain and ship human blood to a Renalytix clinical