Urine Standard, 100 Na 100K

Basic Information

• Brand Name: Urine Standard, 100 Na 100K
• Primary DI: 08426950010906
• Version / Model: 00003510000
• Catalog Number: 00003510000
• Company Name: INSTRUMENTATION LABORATORY COMPANY
• Labeler DUNS: 557223252
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 7
• Public Version Date: 2021-07-13
• Public Version Status: Update
• Public Device Record Key: 79ad6931-eb6a-4808-9ee1-e7e5f674ce63
• Distribution End Date: 2019-09-24

Device Description

Urine Standard, 100 Na 100K

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: 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
JJO	FLAME EMISSION PHOTOMETER FOR CLINICAL USE	Clinical Chemistry	862.2540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
52867	Multiple electrolyte IVD, calibrator	A material which is used to establish known points of reference for a number of assays intended to be used for the quantitative measurement of one or multiple electrolytes in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08426950010906	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K823480	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: The product is stable until the expiration date shown on the box and on the labels when stored at 15-25 °C.