IDG/Sanzay

Basic Information

• Brand Name: IDG/Sanzay
• Primary DI: 00850053916205
• Version / Model: 1
• Catalog Number: HC301
• Company Name: IDG/SANZAY Corporation
• Labeler DUNS: 948875013
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-03
• Public Version: 1
• Public Version Date: 2024-07-11
• Public Version Status: New
• Public Device Record Key: 599ce6d5-2b8a-41d3-ba77-b5d079abbb85

Device Description

Calcium Chloride 0.020 M is a reagent for use only in the in vitro determination of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and recalcification (plasma clotting) time, as well as in various coagulation factor assays

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GJS	Test, Time, Prothrombin	Hematology	864.7750	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	00850053916205	GS1

Premarket Submissions

Submission Number	Supplement Number
K020840	000

Storage Conditions

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