RACT

GUDID 20643169577484

CARTRIDGE 402-02 ACT RACT 13 LAN

MEDTRONIC, INC.

Heparin anti-Xa IVD, kit, chromogenic

• Primary Device ID: 20643169577484
• NIH Device Record Key: 75e36e40-31fe-4b3c-93eb-c5961da5df92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RACT
• Version Model Number: 402-02
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 50
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169577480 [Unit of Use]
GS1	20643169577484 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K853198

FDA Product Code

• JPA: SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES

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: 2018-07-06
• Device Publish Date: 2016-06-13

On-Brand Devices [RACT]

• 20643169577484: CARTRIDGE 402-02 ACT RACT 13 LAN
• 20613994531821: CARTRIDGE 402-02 ACT RACT 14L
• 20613994417286: CARTRIDGE 402-02 ACT RACT 13 LAN
• 00763000433833: CARTRIDGE 402-02 ACT RACT 13 LAN