AccessGUDID - DEVICE: ADVIA Centaur® Systems, ACS:180® Systems HCY Calibrator (00630414468198)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA Centaur® Systems, ACS:180® Systems HCY Calibrator
Version or Model: 10310376
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 124579
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414468198
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Homocysteine - CENTAUR - CAL - 2x2x2mL

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
53749	Homocysteine 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 homocysteine in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIS	CALIBRATOR, PRIMARY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K013406	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store Upright, Protect from Light, Do not freeze, Resuspend.
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e4ef7b79-350d-44c1-93d3-91c43ca58737
Public Version Date: August 20, 2024
Public Version Number: 6
DI Record Publish Date: September 24, 2016