Dimension® Flex® reagent cartridge CRE2

Basic Information

• Brand Name: Dimension® Flex® reagent cartridge CRE2
• Primary DI: 00630414595009
• Version / Model: 10872079
• Catalog Number: DF33B
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 005088112
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 6
• Public Version Date: 2022-12-20
• Public Version Status: Update
• Public Device Record Key: a821bdda-760c-4118-a706-ad9af4a02b7a

Device Description

Creatinine Flex® reagent cartridge, 480 tests

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
CGX	ALKALINE PICRATE, COLORIMETRY, CREATININE	Clinical Chemistry	862.1225	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53251	Creatinine IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of creatinine in a clinical specimen, using a spectrophotometry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414595009	GS1
Unit of Use	00630414006123	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K132638	000

Storage Conditions

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