ACT Plus®

GUDID 00643169178380

INSTRUMENT ACT100 ACT PLUS 110V IVDD

MEDTRONIC, INC.

Coagulation timer IVD

• Primary Device ID: 00643169178380
• NIH Device Record Key: e3facc9b-6ddb-46ca-b1b2-494032ddf78c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACT Plus®
• Version Model Number: ACT100
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• 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: false
• Serial Number: true
• 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 Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169178380 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K940426

FDA Product Code

• GKN: Timer, clot, automated

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: 2016-04-28

On-Brand Devices [ACT Plus®]

• 00613994390714: SCANNER ACTSC FINISHED ACT PLUS C4
• 00643169178410: INSTRUMENT ACT200 ACT PLUS 220VN1 IVDD
• 00643169178380: INSTRUMENT ACT100 ACT PLUS 110V IVDD
• 00721902932946: INSTRUMENT RACT100 ACT PLUS 110V RECOND
• 00721902932939: INSTRUMENT EACT100 ACT PLUS 110V
• 00721902793066: INSTRUMENT ACT100 ACT PLUS 110V
• 00763000135478: SCANNER ACTSC FINISHED ACT PLUS C4 NROHS