AccessGUDID - DEVICE: BVA100 (B641BVA100SOFTWARE60)

GUDID

Device Identifier (DI) Information

Brand Name: BVA100
Version or Model: v6.0.4.
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DAXOR CORPORATION

Primary DI Number: B641BVA100SOFTWARE60
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790888833 *Terms of Use

Device Description: The BVA-100 Software v6.0.4. calculates and reports a blood volume determination based on data retrieved from sampling points taken at timed intervals. The software also determines the patient's ideal blood volume which is derived from the patient's height, weight, and gender. The software compares the computed blood volume against the ideal value to indicate a surplus or deficit in blood volume percentages.

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?
47534	Blood volume analyser IVD	A mains electricity (AC-powered) instrument intended to be used for the quantitative in vitro measurement of a patient's circulating blood volume, plasma volume and/or red cell volume. Measurements are typically performed on blood specimens collected at specified intervals following the introduction of a radioactive tracer (e.g., iodine isotope 131) through an intravenous line, and the dispersion or rate of dilution of the tracer solution is used to determine blood volume by comparing sequential samples to a calculated ideal blood volume based on height, weight, gender and deviation from the patient's ideal weight. It operates with automation of some procedural steps.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JWO	Device, Blood Volume Measuring

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K964406	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: 7cd9c282-40c2-44d3-82ad-9f8614882666
Public Version Date: October 04, 2018
Public Version Number: 1
DI Record Publish Date: September 03, 2018