OSMOCOLL® HNL osmolality Controls, 6x1mL

Basic Information

• Brand Name: OSMOCOLL® HNL osmolality Controls, 6x1mL
• Primary DI: 03661540300196
• Version / Model: SS-273
• Company Name: ELITECHGROUP INC.
• Labeler DUNS: 052423787
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-19
• Public Version: 1
• Public Version Date: 2021-03-01
• Public Version Status: New
• Public Device Record Key: b552b1ff-7aef-42a2-bf9c-87c8e39d336a

Device Description

Osmocoll HNL Osmolality Controls are for use as controls for osmolality determination by a vapor pressure osmometer.

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
52886	Osmolality IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of osmolality of a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03661540300196	GS1

Customer Contacts

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

Storage Conditions

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