EM 15 Blood Glucose Level 1 and Level 2 Control Solution

Basic Information

• Brand Name: EM 15 Blood Glucose Level 1 and Level 2 Control Solution
• Primary DI: 00885017000584
• Version / Model: EM44
• Company Name: EPS BIO TECHNOLOGY CORP.
• Labeler DUNS: 658620117
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-19
• Public Version: 1
• Public Version Date: 2019-07-29
• Public Version Status: New
• Public Device Record Key: 1274c6bb-f89d-4811-929f-92666153a504

Device Description

a bottle of level 1 and a bottle of level 2 control solution

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: Yes
• 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
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41819	Glucose IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00885017000584	GS1
Package	10885017000581	GS1	carton	192	In Commercial Distribution

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 40 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius