TEG HEMOSTASIS SYSTEM

Basic Information

• Brand Name: TEG HEMOSTASIS SYSTEM
• Primary DI: 10812747018043
• Version / Model: 07-012
• Company Name: HAEMONETICS CORPORATION
• Labeler DUNS: 057827420
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-31
• Public Version: 4
• Public Version Date: 2023-10-10
• Public Version Status: Update
• Public Device Record Key: a6958339-a5ae-45c1-87a1-b6af9fcba261

Device Description

CALCIUM CHLORIDE, 0.2M, 5 ML

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: 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
30593	Calcium chloride coagulation reagent IVD	A calcium chloride solution intended to be used alone or in combination with other IVDs in the performance of coagulation tests or other laboratory investigations of clinical specimens.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10812747018043	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K002177	000
K993678	000

Device Sizes

Type	Value	Unit	Text
Total Volume	5	Milliliter