AccessGUDID - DEVICE: BVA-100 Convenience Kits (B641CONVKIT1000)

GUDID

Device Identifier (DI) Information

Brand Name: BVA-100 Convenience Kits
Version or Model: BVA-100 CONVKIT
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DAXOR CORPORATION

Primary DI Number: B641CONVKIT1000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790888833 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
31336	Arterial blood sampling kit	A collection of sterile devices intended to obtain an arterial blood specimen directly from a patient, usually for the determination of blood gas concentration. It typically includes a needle, heparinized syringe, sterile gauze/swab, bandage, rubber band, stopper, and patient identification label. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KST	System, Blood Collection, Vacuum-Assisted, Manual

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: 15d68396-afcd-4752-8652-49abd3fe14ce
Public Version Date: October 08, 2020
Public Version Number: 1
DI Record Publish Date: September 30, 2020