FDA UDI In Commercial Distribution 🇺🇸 United States

BVA-100 Convenience Kits

DI: B641CONVKIT1000 · Model: BVA-100 CONVKIT · DAXOR CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
BVA-100 Convenience Kits
Primary DI
B641CONVKIT1000
Version / Model
BVA-100 CONVKIT
Company Name
DAXOR CORPORATION
Labeler DUNS
790888833
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-09-30
Public Version
1
Public Version Date
2020-10-08
Public Version Status
New
Public Device Record Key
15d68396-afcd-4752-8652-49abd3fe14ce

Device Description

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

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
MR Conditional
Direct Marking Exempt
Yes
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

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

GMDN Terms

Code Name
31336 Arterial blood sampling kit

Identifiers

Type ID
Primary B641CONVKIT1000