KidneyIntelX Blood Collection Convenience Kit

GUDID 00196852040506

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

• Primary Device ID: 00196852040506
• 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	00196852040506 [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: 3
• Public Version Date: 2023-02-28
• 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