SULFOLYSER

Basic Information

• Brand Name: SULFOLYSER
• Primary DI: 00664369200169
• Version / Model: SLS-220A
• Company Name: SYSMEX CORPORATION
• Labeler DUNS: 690664461
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-04
• Public Version: 1
• Public Version Date: 2022-11-14
• Public Version Status: New
• Public Device Record Key: 072cd40c-1ab7-4dd6-96c3-71e9faa4d12a

Device Description

Reagent for the automated determination of hemoglobin concentration of blood

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: Yes
• 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
GGK	Products, Red-Cell Lysing Products	Hematology	864.8540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
55875	Total haemoglobin (totHb) 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 total haemoglobin (totHb) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00664369200169	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	5	Liter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 1 – 30 Degrees Celsius