AccessGUDID - DEVICE: Dimension® HCG Calibrator (00842768013737)

GUDID

Device Identifier (DI) Information

Brand Name: Dimension® HCG Calibrator
Version or Model: 10445019
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RC430
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768013737
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: Human Chorionic Gonadotropin Calibrator, 2x5x2mL

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?
38263	Total human chorionic gonadotropin 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 total human chorionic gonadotropin (HCG), which includes a combination of intact HCG, nicked HCG, alpha-HCG subunits, and beta-HCG subunits, in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIW	CALIBRATOR, SURROGATE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K970396	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: e55f9a9a-2247-4a93-bc31-0ca17d88150c
Public Version Date: July 06, 2023
Public Version Number: 6
DI Record Publish Date: September 24, 2016