FDA.reportPublic FDA data

VASOBand

Primary DI
00860004749745
Brand
VASOBand
Company
VASOINNOVATIONS INC.
Model
VB-2900-AL
Catalog number
VB-2900-AL
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
00860004749745PackageGS15In Commercial Distribution
00866691000343PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860004749745008600047497458600047497450860004749745
00866691000343008666910003438666910003430866691000343

GMDN Terms#

Term, Definition table
TermDefinition
Radial artery compression deviceA sterile 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
Circumference29Centimeter

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
071926350
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00866691000305VASOBandVB-2600-ALVB-2600-AL2021-01-05
00866691000329VASOBandVB-2600-ARLVB-2600-ARL2021-01-05
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
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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