FDA.reportPublic FDA data

BV Medical

Primary DI
00845821026507
Brand
BV Medical
Company
BV Medical
Model
50-100-004-L
Device description
Finger Pulse Oximeter, Basic Adult Model, with Carrying Case
Published
2016-12-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063641000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063641000PC-60, NON-INVASIVEPULSE OXIMETERShenzhen Creative Industry Co., Ltd.2007-07-13DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845821026507PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845821026507008458210265078458210265070845821026507

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen saturation/pulse rate simulatorAn electronic instrument designed to simulate arterial oxygen saturation and/or pulse rate for testing and calibrating pulse oximeters, pulse oximeter probes and other related pulse oximetry devices.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
105932508
Device count
1
Lot or batch
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
06924054300906BERRYSHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-07-30
04048675785910Masimo SpO2 Module for Vista 300/SShanghai Draeger Medical Instrument Co.,Ltd.DQA2026-07-13
00010939962218N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00093351041099N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013550N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013567N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113849N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113856N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06931973400563CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
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