Dimension® Flex® reagent cartridge IRON

Basic Information

• Brand Name: Dimension® Flex® reagent cartridge IRON
• Primary DI: 00842768020414
• Version / Model: 10444945
• Catalog Number: DF85
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 005088112
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• 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: eb419c12-5059-4b83-8e59-16ddf3598eb0

Device Description

Iron Flex® reagent cartridge, 240 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
JIY	Photometric method, iron (non-heme)	Clinical Chemistry	862.1410	1

GMDN Terms

Code	Name	Definition	Implantable	Status
54757	Iron IVD, kit, enzyme spectrophotometry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of iron in a clinical specimen, using an enzyme spectrophotometry method.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842768020414	GS1
Unit of Use	00630414004327	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K060264	000

Storage Conditions

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