RL 1200 Waste Bottle Kit

Basic Information

• Brand Name: RL 1200 Waste Bottle Kit
• Primary DI: 00630414515144
• Version / Model: 10324896
• Catalog Number: 6641057
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 064608573
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 6
• Public Version Date: 2023-08-18
• Public Version Status: Update
• Public Device Record Key: 4c4b6ebe-ccf4-45eb-9fea-1c112527e1fa

Device Description

Waste Bottle Kit. An in vitro diagnostics device for use on the RAPIDLab® 1200 series analyzer.

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: No
• 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
CHL	ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH	Clinical Chemistry	862.1120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
14426	Contaminated waste container	A container made of metal, hard plastic and/or cardboard designed for the safe deposit, collection and storage of contaminated and/or otherwise hazardous biological materials (e.g., waste products containing or having been in contact with human blood, sputum, urine and/or faeces). It is not intended to exclusively contain sharps or for in vitro diagnostic purposes. It is typically used with a disposable liner and has a self-closing lid. It is typically identified with a contaminated material symbol on its labelling. The contents will be sent to disposal usually by incineration. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414515144	GS1
Unit of Use	00630414010489	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K934907	000