PL Chip Reservoir Set

Basic Information

• Brand Name: PL Chip Reservoir Set
• Primary DI: 04589448510099
• Version / Model: N/A
• Catalog Number: 18003
• Company Name: ZACROS CORPORATION
• Labeler DUNS: 690584370
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2024-12-12
• Public Version: 1
• Public Version Date: 2024-12-20
• Public Version Status: New
• Public Device Record Key: 5cd9a68a-3cfc-4999-ade4-0bdd1befa57b

Device Description

Disposable accessories for use with the PL Chip

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: 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
JOZ	System, Automated Platelet Aggregation	Hematology	864.5700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62225	Assay container IVD, single-use	A reservoir (e.g., bottle, tube, cup) intended to be used to contain volumes of reagent, buffers, biological specimens, or other materials in preparation for in vitro diagnostic testing procedures performed in the laboratory. It is typically made of plastic or glass and may be used on the benchtop for manual procedures, or on-board automated liquid handling instruments or analysers. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	14589448510096	GS1
Primary	04589448510099	GS1

Premarket Submissions

Submission Number	Supplement Number
K191364	000