FDA.reportPublic FDA data

BiDop 7 probe

Primary DI
00894912002692
Brand
BiDop 7 probe
Company
KOVEN TECHNOLOGY, INC.
Model
PG-30
Catalog number
PG-30
Device description
PPG Probe for Bidop 7
Published
2021-01-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DPWFlowmeter, Blood, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPWFlowmeter, Blood, CardiovascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201114000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201114000Bidop 7Koven Technology, Inc.2021-01-05DPW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00894912002692PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00894912002692008949120026928949120026920894912002692

GMDN Terms#

Term, Definition table
TermDefinition
Limb plethysmograph phototransducerA photoelectric device designed to be applied externally to a portion of a limb (e.g., a fingertip, toe) for the transcutaneous measurement of blood volume using light detection during limb plethysmography. It is intended to be connected to a limb plethysmograph (not included), whereby volume changes are represented graphically to represent blood flow/pulse. It is designed for use during vascular function assessment in a limb (e.g., measurement of toe brachial pressure index). Although similar to a pulse oximeter probe, it is dedicated to limb plethysmography, and not capable of oxygen saturation measurements. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
314-542-2101info@koven.com

Regulatory Flags#

DUNS number
069261402
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00894912002173ES102EXES102EXES102EX2016-02-24
00894912002180DVM 4500DVM 4500DVM 45002016-03-10
00894912002302BT10M5S8ABT10M5S8ABT10M5S8A2016-03-10
00894912002319BT10M5S8CBT10M5S8CBT10M5S8C2016-03-10
00894912002333BT5M05S8ABT5M05S8ABT5M05S8A2016-03-10
00894912002340BT5M05S8CBT5M05S8CBT5M05S8C2016-03-10
00894912002357BT8M05S8ABT8M05S8ABT8M05S8A2016-03-09
00894912002364BT8M05S8CBT8M05S8CBT8M05S8C2016-03-10
00894912002425T10M5S8CT10M5S8CT10M5S8C2016-03-10
00894912002449T5M05S8CT5M05S8CT5M05S8C2016-03-10
00894912002456T8M05S8CT8M05S8CT8M05S8C2016-03-10
00894912002975BT5M05S8ABT5M05S8ABT5M05S8A2016-07-06
00894912002432T2M20S8CT2M20S8CT2M20S8C2016-03-10
00894912002463T2M25N8AT2M25N8AT2M25N8A2016-03-10
00894912002876Pencil probeBP5M05S8ABP5M05S8A2016-06-29
00894912002890Pencil probeBP10M5S8ABP10M5S8A2016-06-29
00894912002883Pencil probeBP8M05S8ABP8M05S8A2018-04-10
00894912002036CTCT-4CT-42020-04-03
00894912002326BT2M20S8CBT2M20S8CBT2M20S8C2016-03-10
00894912002067PAUS2.0PAUS2.02025-01-01

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