Emit II Plus Specialty Multi Drug Calibrator/Control Level 3

Basic Information

• Brand Name: Emit II Plus Specialty Multi Drug Calibrator/Control Level 3
• Primary DI: 00630414027951
• Version / Model: 10720814
• Catalog Number: 9T569UL
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 005088112
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-09
• Public Version: 3
• Public Version Date: 2021-11-18
• Public Version Status: Update
• Public Device Record Key: 028b28a5-25e1-4ab5-aace-03cbc4e6a6c0

Device Description

Emit II Plus Specialty Multi Drug Calibrator/Control Level 3

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
LAS	Drug specific control materials	Clinical Toxicology	862.3280	1
DLJ	Calibrators, drug specific	Clinical Toxicology	862.3200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55460	Multiple drugs of abuse IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of one or multiple drugs of abuse in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414027951	GS1

Customer Contacts

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

Storage Conditions

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