Dimension Vista®/Dimension® EXL™ CTNI SDIL

Basic Information

• Brand Name: Dimension Vista®/Dimension® EXL™ CTNI SDIL
• Primary DI: 00842768015892
• Version / Model: 10445205
• Catalog Number: KD692
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 005088112
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 6
• Public Version Date: 2023-06-02
• Public Version Status: Update
• Public Device Record Key: f8dca0f4-868f-4b4b-9c72-da1cf02869e8

Device Description

CTNI Sample Diluent, 6x2.5mL

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
MMI	IMMUNOASSAY METHOD, TROPONIN SUBUNIT	Clinical Chemistry	862.1215	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58237	Buffered sample diluent IVD	A buffered diluent solution intended to be used as a consumable reagent during manual procedures or on-board an automated or semi-automated instrument (e.g., haematological cell analyser) for the processing, staining and/or testing of clinical laboratory specimens (e.g., whole blood).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842768015892	GS1
Unit of Use	00630414005348	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K081643	000

Storage Conditions

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