AccessGUDID - DEVICE: Stratus® CS Acute Care™ ßhCG CalPak (00842768004414)

GUDID

Device Identifier (DI) Information

Brand Name: Stratus® CS Acute Care™ ßhCG CalPak
Version or Model: 10445061
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CBHCG-C
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768004414
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: The Status® CS Acute Care(TM) Beta human Chorionic Gonadotropin CalPak calibrator (ßhCG CalPak) is an in vitro diagnostic product intended to be used for calibration of the Stratus® CS Acute Care(TM) ßhCG method.

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:	Yes
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?
58789	Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of beta-subunit human chorionic gonadotropin (beta-HCG), which may include free beta-HCG subunit, free nicked beta-HCG subunit and/or beta subunit core fragment, in a clinical specimen using a fluorescent immunoassay method.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
NBC	TEST,NATRIURETIC PEPTIDE
JIT	CALIBRATOR, SECONDARY
DHA	SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K060548	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: 83cf552f-4a83-48b5-b3ad-26dd1bb9dfcb
Public Version Date: November 19, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016