Drew Scientific

Basic Information

• Brand Name: Drew Scientific
• Primary DI: 00817274020609
• Version / Model: EX-PAC2
• Company Name: DREW SCIENTIFIC, INC.
• Labeler DUNS: 144968104
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 1442ea6b-1832-49cb-aa35-99e808d0cf61

Device Description

Excell 3-Part Hematology Reagent Pack

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: 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
55949	Red cell glucose phosphate isomerase (GPI) 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 quantitative measurement of glucose phosphate isomerase (GPI) enzyme activity in red blood cells from a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817274020609	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 18 – 30 Degrees Celsius