AccessGUDID - DEVICE: Dimension® CCRP Calibrator (00842768016011)

GUDID

Device Identifier (DI) Information

Brand Name: Dimension® CCRP Calibrator
Version or Model: 10445003
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RC434
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768016011
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: CardioPhase® hsCRP Calibrator, 2x5x1mL

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):	Yes
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?
41838	C-reactive protein (CRP) 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 C-reactive protein (CRP) in a clinical specimen [includes high-sensitivity CRP (hsCRP) types].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIS	CALIBRATOR, PRIMARY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K053104	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
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: 48e45e34-748b-4a01-874f-4c04d82f9e9a
Public Version Date: June 10, 2022
Public Version Number: 6
DI Record Publish Date: September 24, 2016