Hemostasis System

Basic Information

• Brand Name: Hemostasis System
• Primary DI: 10812747018463
• Version / Model: 07-605-US
• Company Name: HAEMONETICS CORPORATION
• Labeler DUNS: 057827420
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-17
• Public Version: 1
• Public Version Date: 2021-06-25
• Public Version Status: New
• Public Device Record Key: 67822efe-b83d-4a38-aa1b-e5b5573336ea

Device Description

Citrated: K, RT, FF

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: Yes
• 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
30595	Multiple coagulation factor IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is 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
Package	20812747018460	GS1		10	In Commercial Distribution
Primary	10812747018463	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K183160	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius