DAXOR CORPORATION

Address:107 Meco Lane,Oak Ridge,TN,37830,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Syringe, Piston (FMF) (2) Device, Blood Volume Measuring (JWO) (1) Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use (LXG) (1) System, Blood Collection, Vacuum-Assisted, Manual (KST) (1)

Premarket Exempt

No Yes

Clear

BVA100 - B641BVA100SOFTWARE60 Catalog Number :

Device Description : The BVA-100 Software v6.0.4. calculates and reports a blood volume determination 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 Class : 2

Duns Number: 790888833

Premarket Exempt : No

Product Code : JWO

Prescription Use : No

Device Count : 1

BVA-100 Convenience Kits - B641CONVKIT1000 Catalog Number :

Device Description : Collection of medical components used to withdraw blood samples for use in deter Collection of medical components used to withdraw blood samples for use in determinations of total blood and plasma volumes.

Device Class : 1

Duns Number: 790888833

Premarket Exempt : Yes

Product Code : KST

Prescription Use : Yes

Device Count : 1

MAX-100 - B641MAX1000 Catalog Number :

Device Description : Sterile syringe delivery device used to deliver (inject) Volumex (Iodinated I-13 Sterile syringe delivery device used to deliver (inject) Volumex (Iodinated I-131Allbumin injection) for use in determinations of total blood and plasma volumes.

Device Class :

Duns Number: 790888833

Premarket Exempt : No

Product Code : FMF

Prescription Use : No

Device Count : 1

MAX-100 - B641MAX10055 Catalog Number :

Device Description : Sterile Syringe delivery device used to deliver (inject) Volumex (I-131 HSA) for Sterile Syringe delivery device used to deliver (inject) Volumex (I-131 HSA) for use in determination of total blood and plasma volumes.

Device Class : 2

Duns Number: 790888833

Premarket Exempt : Yes

Product Code : FMF

Prescription Use : Yes

Device Count : 1

BVA100 - B641SC25MK20 Catalog Number :

Device Description : An electro-mechanical carousel instrument that provides movement and placement o An electro-mechanical carousel instrument that provides movement and placement of blood plasma specimens to ensure the proper counting sequence for a blood volume test.

Device Class : 1

Duns Number: 790888833

Premarket Exempt : Yes

Product Code : LXG

Prescription Use : No

Device Count : 1

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