Drew Scientific

Basic Information

• Brand Name: Drew Scientific
• Primary DI: 00817274020487
• Version / Model: RA-9020
• Catalog Number: RA-9020
• Company Name: DREW SCIENTIFIC, INC.
• Labeler DUNS: 144968104
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-07
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 7eadb589-30bf-48eb-b2a3-72186f189444

Device Description

Differential Lyse (20L)

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
55854	Full blood count IVD, kit, cell count	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of one or multiple whole blood cell parameters [also known as complete blood count (CBC)] in a clinical specimen using a manual, semi-automated or automated cell count method. Test components may include white cell count and differential, haemoglobin determination, red cell count, red cell characterization and calculation of red cell parameters, and/or platelet count.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817274020487	GS1

Customer Contacts

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

Storage Conditions

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