FDA.reportPublic FDA data

BV Medical

Primary DI
00845821027573
Brand
BV Medical
Company
BV Medical
Model
80-806-254
Device description
Velcro tourniquet, reusable, adult, latex free, royal blue, each
Published
2018-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAXTourniquet, Nonpneumatic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAXTourniquet, NonpneumaticGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845821027573PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845821027573008458210275738458210275730845821027573

GMDN Terms#

Term, Definition table
TermDefinition
Tourniquet cuff, reusableA band-like device that is applied around an extremity (arm or leg) and connected to a tourniquet unit to apply a controlled pressure to restrict blood circulation and prevent normal blood flow to or from the distal area during a surgical intervention or serious injury. The tourniquet unit is used to provide the pressure within the cuff and display the pressure applied. The cuff usually comprises a dual-chamber allowing for alternation of the pressure site to avoid tissue damage or necrosis. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)822-8293info@bvmedical.com

Regulatory Flags#

DUNS number
105932508
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845821027313BV Medical 80-800-000-L2017-12-10
00845821031945BV Medical38-416-334-502019-06-18
00845821000088BV Medical38-416-3042018-07-25
00845821000095BV Medical30-416-3042018-07-12
00845821001559BV Medical20-380-014-L2018-09-24
00845821001566BV Medical20-380-054-L2018-09-24
00845821001573BV Medical20-380-164-L2018-09-24
00845821001597BV Medical20-380-254-L2018-09-24
00845821001603BV Medical20-380-274-L2018-09-24
00845821001610BV Medical20-480-014-L2018-09-24
00845821001627BV Medical20-480-054-L2018-09-24
00845821001634BV Medical20-480-164-L2018-09-24
00845821001641BV Medical20-480-234-L2018-09-03
00845821001658BV Medical20-480-254-L2018-09-24
00845821001665BV Medical20-480-274-L2018-09-24
00845821001672BV Medical20-708-014-L2018-09-24
00845821002464BV Medical 38-411-2842018-07-10
00845821002471BV Medical38-416-1942018-07-25
00845821002570BV Medical 38-411-2442018-07-10
00845821003652BV Medical30-176-2842018-07-10

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Primary DI, Brand, Company table
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