AccessGUDID - DEVICE: BN II Additive (00842768007781)

GUDID

Device Identifier (DI) Information

Brand Name: BN II Additive
Version or Model: 10446098
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OQKY61
Company Name: Siemens Healthcare Diagnostics Products GmbH

Primary DI Number: 00842768007781
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 388240673 *Terms of Use

Device Description: Washing Solution (concentrate) for cleaning the cuvettes in the BN II System

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?
58236	Buffered wash solution IVD	A buffered wash solution intended to be used as a consumable reagent in combination with other IVDs during manual procedures or on-board an automated or semi-automated instrument for the processing, staining and/or testing of clinical laboratory specimens to neutralize/wash/rinse away excess reactants and/or to function as a wetting agent.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JZW	NEPHELOMETER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K001647	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: d009088f-6226-4aa0-9428-420649a9d474
Public Version Date: June 02, 2023
Public Version Number: 3
DI Record Publish Date: September 24, 2020