FDA.reportPublic FDA data

BV Medical

Primary DI
00845821011480
Brand
BV Medical
Company
BV Medical
Model
90-001-250
Device description
CPR Mask With One Way Valve and Carrying Case Single use.
Published
2018-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAEAirway, Oropharyngeal, Anesthesiology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAEAirway, Oropharyngeal, AnesthesiologyAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845821011480PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845821011480008458210114808458210114800845821011480

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary resuscitation mask, single-useA flexible, form-shaped device that is placed over a patient's mouth to administer "mouth-to-mask" exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR). The device is designed to replace "mouth-to-mouth" resuscitation therefore reducing the risk of cross-contamination; it is also used on manikins by students during CPR training. The device typically consists of the mask with a mouthpiece and a non-rebreathing valve and/or bacteria filter. Also referred to as a pocket face mask, it is typically used by emergency medical services (EMS) or as part of first aid kits. This is a single-use 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04816415501409SINGLE-USE OROPHARYNGEAL AIRWAY 40 mmASSOMEDIKA, OOOCAE2026-05-27
04816415501416SINGLE-USE OROPHARYNGEAL AIRWAY 90 mmASSOMEDIKA, OOOCAE2026-05-27
04816415501423SINGLE-USE OROPHARYNGEAL AIRWAY 110 mmASSOMEDIKA, OOOCAE2026-05-27
10197344165605MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10197344165612MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10197344165629MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10197344165636MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10197344165643MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10197344165650MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10197344165667MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10197344165674MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
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