Dimension® Flex® reagent cartridge CKI

Basic Information

• Brand Name: Dimension® Flex® reagent cartridge CKI
• Primary DI: 00842768025525
• Version / Model: 10464511
• Catalog Number: DF38
• 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: 7
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: fecb9393-53be-4c81-bf02-a1425fa6e8c6

Device Description

Creatine Kinase 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
JHS	DIFFERENTIAL RATE KINETIC METHOD, CPK OR ISOENZYMES	Clinical Chemistry	862.1215	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53003	Total creatine kinase (CK) IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total creatine kinase (CK) 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	00842768025525	GS1
Unit of Use	00630414005645	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K081731	000

Storage Conditions

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