Advanced Instruments Microsample Test Kit, Plunger Wire, 500 Tips/Cleaners

Basic Information

• Brand Name: Advanced Instruments Microsample Test Kit, Plunger Wire, 500 Tips/Cleaners
• Primary DI: 00816068020498
• Version / Model: 133800
• Catalog Number: 133800
• Company Name: ADVANCED INSTRUMENTS, INC.
• Labeler DUNS: 125006353
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-22
• Public Version: 1
• Public Version Date: 2019-04-01
• Public Version Status: New
• Public Device Record Key: 64e59009-7519-4183-b0e2-e966ee000da4

Device Description

For In vitro diagnostic use. The Advanced™ Micro-Sample Test Kit conveniently supplies the consumables needed for osmolality testing: 500 sampler tips, 500 chamber cleaners, and one replacement plunger wire.

Device Characteristics

• Single Use: Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JJM	Osmometer For Clinical Use	Clinical Chemistry	862.2730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
52884	Osmolality IVD, kit, freezing point	A collection of reagents and other associated materials intended to be used for the quantitative measurement of osmolality of a clinical specimen, using a freezing point method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816068020498	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius