FDA.reportPublic FDA data

BV Medical

Primary DI
00845821026279
Brand
BV Medical
Company
BV Medical
Model
20-443-344-OTO-L
Device description
Combo Kit: Royal Blue Fanny Pack: 38-416-344 Sprague Rappaport-Type, Adult, Frosted Blue, Latex Free: 60-870-010 PICCOLIGHT® F.O. Xenon 2.5V Otoscope, Black, Latex Free: 20-207-254-L Classic Aneroid Sphygmomanometer, Royal Blue Nylon Cuff, Adult, Latex: 60-405-250 LED Penlight, Metal, Push Button, Cobalt Blue: 8-380J Fiberglass Tape Measure, BV Logo Sticker, White Case: 80-170-150 Utility scissors 5.5", stainless steel with light blue handle: 80-503-000 Babinski hammer, 8.5"
Published
2018-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXQBlood Pressure Cuff

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXQBlood Pressure CuffCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845821026279PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845821026279008458210262798458210262790845821026279

GMDN Terms#

Term, Definition table
TermDefinition
Otoscope, directA portable, battery-powered, hand-held device (non-endoscopic) primarily designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. The device consists of a handle that contains the batteries (which may be rechargeable), a built-in light to illuminate the interior of the ear canal, and a detachable cone-shaped tube (the speculum) that is inserted in the ear canal. In some cases a moderate air pressure may be applied. Supplemental devices (e.g., additional specula, spare light bulbs) may be included. 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845821032737BV Medical 40-208-000-BULK2022-03-31
00845821032478BV Medical20-218-014-AUTISM-L2021-03-12
00845821032485BV Medical20-218-015-AUTISM-L2021-03-12
00845821032492BV Medical20-218-013-AUTISM-L2021-03-12
00845821032393BV Medical 40-101-900-L2020-12-16
00845821028327School Health20-218-014-SH-L2016-12-24
00845821032027BV Medical80-700-1902019-09-06
00845821032034BV Medical80-700-2502019-09-06
00845821031990BV Medical80-700-0002019-08-22
00845821010513BV Medical80-172-0002018-09-24
00845821010520BV Medical80-173-0002018-09-24
00845821010537BV Medical80-174-0002018-09-24
00845821010544BV Medical80-174-0102018-09-24
00845821010551BV Medical80-174-0702018-09-24
00845821010568BV Medical80-174-0602018-09-24
00845821010575BV Medical80-174-1302018-09-24
00845821010582BV Medical80-174-2502018-09-24
00845821010599BV Medical80-175-0002018-09-24
00845821010605BV Medical80-176-0002018-09-24
00845821010612BV Medical80-177-0002018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00634782902636Adcuff™ AMERICAN DIAGNOSTIC CORPDXQ2026-02-23
M3681097002GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M3682338A1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M3682338X1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823452A1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823452C1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823452X1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823481A1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823552N1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823552X1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823562A1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823562C1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823562N1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823562X1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823572A1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M3682360A1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M3682362X2GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
00810079260089Teladoc Health, Inc.Teladoc Health, Inc.DXQ2026-02-17
16978034830133tenoviShenzhen Jamr Medical Technology Co., Ltd.DXQ2025-12-12
16978034830140tenoviShenzhen Jamr Medical Technology Co., Ltd.DXQ2025-12-12
10840935111702Straight Black Hose, Female Bayonet to Female Bayonet, 9.8ft (3m), SiemensSUNTECH MEDICAL, INC.DXQ2025-12-01
10840935111719Straight Gray Hose, Female Luer to Female Bayonet, 9.8ft (3m), SiemensSUNTECH MEDICAL, INC.DXQ2025-12-01
10840935111696Patient HoseSUNTECH MEDICAL, INC.DXQ2025-11-18
20197344165343MEDLINEMEDLINE INDUSTRIES, INC.DXQ2025-11-14
20197344165374MEDLINEMEDLINE INDUSTRIES, INC.DXQ2025-11-14
20197344165398MEDLINEMEDLINE INDUSTRIES, INC.DXQ2025-11-14
10197344165339MEDLINEMEDLINE INDUSTRIES, INC.DXQ2025-11-14
10197344165353MEDLINEMEDLINE INDUSTRIES, INC.DXQ2025-11-14
10197344165360MEDLINEMEDLINE INDUSTRIES, INC.DXQ2025-11-14
10197344165384MEDLINEMEDLINE INDUSTRIES, INC.DXQ2025-11-14