NA

Basic Information

• Brand Name: NA
• Primary DI: 20613994923336
• Version / Model: 306-09POR
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-07-29
• Public Version: 4
• Public Version Date: 2023-10-09
• Public Version Status: Update
• Public Device Record Key: 190ce211-14af-4ea1-b361-147def521160

Device Description

CONTROL 306-09POR PORC PUR/BLK 6L 10BX

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: Yes
• 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
GGN	PLASMA, COAGULATION CONTROL	Hematology	864.5425	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	20613994923336	GS1
Unit of Use	00613994923332	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 10 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Lyophilized Heparin Assay Controls must be refrigerated (2°C to 10°C) until use. Once reconstituted, controls are stable for 2 hours at refrigerated or room temperature (2°C to 25°C).