AccessGUDID - DEVICE: BN II System (00630414002903)

GUDID

Device Identifier (DI) Information

Brand Name: BN II System
Version or Model: 11254820
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OVIA112
Company Name: Siemens Healthcare Diagnostics Products GmbH

Primary DI Number: 00630414002903
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 388240673 *Terms of Use

Device Description: The BN II is a system for the quantitative determination of proteins in serum, plasma, urine and CSF

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?
56728	Nephelometry immunoassay analyser IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a clinical specimen using an immunological method which utilizes a nephelometric detection system to determine the rate and/or quantity of particle agglutination occurring through the formation of immune complexes, together with sample processing, data processing and/or data display software.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DEW	IGG, ANTIGEN, ANTISERUM, CONTROL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K943997	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 163a51c9-4cfe-4570-a99e-6e766d67f46b
Public Version Date: September 16, 2022
Public Version Number: 3
DI Record Publish Date: September 24, 2020