IMMULITE® Probe Cleaning Kit

Basic Information

• Brand Name: IMMULITE® Probe Cleaning Kit
• Primary DI: 00842768028441
• Version / Model: 10385332
• Catalog Number: LKPM
• Company Name: Siemens Healthcare Diagnostics Products GmbH
• Labeler DUNS: 388240673
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-24
• Public Version: 2
• Public Version Date: 2021-11-18
• Public Version Status: Update
• Public Device Record Key: 54af0fba-981e-4ae3-b5a3-3dceaf7c7be8

Device Description

For use in daily maintenance of the IMMULITE® and IMMULITE® 1000 systems

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: 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
JJQ	COLORIMETER, PHOTOMETER, SPECTROPHOTOMETER FOR CLINICAL USE	Clinical Chemistry	862.2300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
59058	Wash/cleaning solution IVD, automated/semi-automated system	A concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument that is used for the processing, staining and/or testing of clinical laboratory specimens.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842768028441	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K905215	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 28 Degrees Celsius