CLOTtrac®

Basic Information

• Brand Name: CLOTtrac®
• Primary DI: 10885074184828
• Version / Model: 550-01
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 15
• Record Status: Published
• Publish Date: 2016-07-17
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 781baa50-5c47-48a1-b3c6-774b430f8c9d

Device Description

CONTROL 550-01 CLOTTRAC CWB 11L 15BX

Device Characteristics

• Single Use: Yes
• 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: No
• Has Lot/Batch Number: Yes
• 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
JPA	SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES	Hematology	864.5425	2

GMDN Terms

Code	Name	Definition	Implantable	Status
30590	Multiple coagulation factor IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10885074184828	GS1
Unit of Use	00885074184821	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K894359	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Upon receipt, the control should be stored refrigerated, from 2° to 10°C, until use. Once reconstituted, the control is stable for 2 hours at room temperature, 15° to 25°C.
• Type: Storage Environment Temperature
• Temperature Range: 2 – 10 Degrees Celsius