ACT Plus®

Basic Information

• Brand Name: ACT Plus®
• Primary DI: 00643169178380
• Version / Model: ACT100
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-04-28
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: e3facc9b-6ddb-46ca-b1b2-494032ddf78c

Device Description

INSTRUMENT ACT100 ACT PLUS 110V IVDD

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GKN	Timer, clot, automated	Hematology	864.5400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35505	Coagulation timer IVD	An electronic device that is used to measure, indicate, and/or record the length of time taken for plasma or a whole blood sample to form a clot following the initiation of a reaction, typically as part of in vitro coagulation studies.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00643169178380	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K940426	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 49 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 5 – 90 Percent (%) Relative Humidity