FDA.reportPublic FDA data

VASOBand

Primary DI
00866691000329
Brand
VASOBand
Company
VASOINNOVATIONS INC.
Model
VB-2600-ARL
Catalog number
VB-2600-ARL
Device description
The VASOBand is a compression device to assist hemostasis of the radial artery after a transradial procedure.
Published
2021-01-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXCClamp, Vascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXCClamp, VascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190318000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190318000VASOBand Vascular Compression DeviceVasoinnovations, Inc.2019-03-14DXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860004749721PackageGS15In Commercial Distribution
00866691000329PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860004749721008600047497218600047497210860004749721
00866691000329008666910003298666910003290866691000329

GMDN Terms#

Term, Definition table
TermDefinition
Radial artery compression deviceA device intended to provide compression for haemostasis to the puncture site on a patient having undergone radial artery catheterization, and can be used as an alternative to direct hand pressure. It typically consists of one or more pad/strap(s), which may also have a compression/decompression knob and a time indicator; it may be applied so that it does not compress the ulna artery or block venous return. It is typically used following coronary angiography/ventriculography or percutaneous transluminal coronary angioplasty (PTCA). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Circumference26Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid exposure to water, direct sunlight, or extreme temperatures or high humidity
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature4 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
(323) 999-7562support@vasoinnovations.com

Regulatory Flags#

DUNS number
071926350
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00866691000305VASOBandVB-2600-ALVB-2600-AL2021-01-05
00866691000336VASOBandVB-2900-ARVB-2900-AR2021-01-05
00866691000343VASOBandVB-2900-ALVB-2900-AL2021-01-05
00866691000350VASOBandVB-2900-ARLVB-2900-ARL2021-01-05
00866691000312VASOBandVB-2600-ARVB-2600-AR2021-01-05
00860004749714VASOBandVB-2600-ALVB-2600-AL2021-01-05
00860004749721VASOBandVB-2600-ARLVB-2600-ARL2021-01-05
00860004749738VASOBandVB-2900-ARVB-2900-AR2021-01-05
00860004749745VASOBandVB-2900-ALVB-2900-AL2021-01-05
00860004749752VASOBandVB-2900-ARLVB-2900-ARL2021-01-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810220800348Adler Instrument CompanyAdler, Inc.DXC2026-06-02
10197344138890NAMICMEDLINE INDUSTRIES, INC.DXC2026-03-16
08022057015884DeTACH Aortic Cross Clamp Head-LargeCORCYM SRLDXC2026-02-03
08022057015907DeTACH Aortic Cross Clamp Head-SmallCORCYM SRLDXC2026-02-03
10193489727173Medline Industries, Inc.MEDLINE INDUSTRIES, INC.DXC2022-08-04
10195594150808CARDINAL HEALTHCardinal Health 200, LLCDXC2021-07-09
M20630300D-Stat® Clamp topical hemostat accessoryVascular Solutions, Inc.DXC2016-09-15
M20635240Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
M20635270Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
M20635290Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
M20635370Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05
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