BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

Dimension Vista® CHEM 1 CAL

DI: 00630414948508 · Model: 10716281 · Siemens Healthcare Diagnostics Inc.

View on AccessGUDID

Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

Let the assistant research this device

The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Brand Name: Dimension Vista® CHEM 1 CAL
Primary DI: 00630414948508
Version / Model: 10716281
Catalog Number: KC110B
Company Name: Siemens Healthcare Diagnostics Inc.
Labeler DUNS: 005088112
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-09-24
Public Version: 7
Public Version Date: 2022-03-04
Public Version Status: Update
Public Device Record Key: c61d77ba-7baf-4c18-97ed-8fc486081c05
Distribution End Date: 2022-03-03

Device Description

Chemistry 1 Calibrator, 6 (3A x 2.3 mL; 3B x 2.3 mL)

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
JIX	CALIBRATOR, MULTI-ANALYTE MIXTURE	Clinical Chemistry	862.1150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47868	Multiple-type clinical chemistry analyte profile IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414948508	GS1

Customer Contacts

Phone: +1(800)441-9250
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K140790	000

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: -70 – -20 Degrees Celsius