FDA.reportPublic FDA data

BT8M05S8AXT

Primary DI
00894912002937
Brand
BT8M05S8AXT
Company
KOVEN TECHNOLOGY, INC.
Model
BT8M05S8AXT
Catalog number
BT8M05S8AXT
Device description
8 MHz CW Doppler probe for the Smartdop XT.
Published
2016-06-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JOPTransducer, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOPTransducer, UltrasonicCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K934638000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K934638000REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8Koven Technology, Inc.1994-05-13JOP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00894912002937PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00894912002937008949120029378949120029370894912002937

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive vascular ultrasound system probeA hand-operated component of a noninvasive vascular ultrasound system intended to be placed on the surface of a patient's body to measure the flow of blood in the underlying vasculature using ultrasonic/Doppler/transit time technology. It may include single or multiple element transducer configurations that convert electric voltages into an ultrasound beam reproducing movement and flow graphically, typically with sound. The device is available in various frequency capacities (e.g., 4, 5, or 8 MHz). It may also be used to detect the foetal heartbeat. This is a reusable device.

Sterilization Methods#

Method table
Method

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888937029536CooperSurgical® Coopersurgical, Inc.JOP2026-04-10
G677H1V06VasoGuardCorVascularJOP2026-04-08
G677H1V08VasoGuardCorVascularJOP2026-04-08
G677H1V10VasoGuardCorVascularJOP2026-04-08
G677H2V02VasoGuardCorVascularJOP2026-04-08
G677H2V04VasoGuardCorVascularJOP2026-04-08
G677VG0201VasoGuardCorVascularJOP2026-04-08
G677VG0401VasoGuardCorVascularJOP2026-04-08
G677VG0601VasoGuardCorVascularJOP2026-04-08
G677VG0801VasoGuardCorVascularJOP2026-04-08
G677VG1001VasoGuardCorVascularJOP2026-04-08
00888937027815CooperSurgical® Coopersurgical, Inc.JOP2026-04-01
00888937027839CooperSurgical® Coopersurgical, Inc.JOP2026-04-01
00888937027808CooperSurgical® Coopersurgical, Inc.JOP2026-01-23
00888937027822CooperSurgical® Coopersurgical, Inc.JOP2025-09-25
07290016880441Detachable PPG Clip sensorVIASONIX LTDJOP2024-12-27
07290016880533Falcon/XpressVIASONIX LTDJOP2024-12-27
07290016880489Pressure Cuff Size 12LVIASONIX LTDJOP2023-06-29
07290016880496Pressure Cuff Size 2.5VIASONIX LTDJOP2023-06-29
07290016880502Pressure Cuff Size 1.9VIASONIX LTDJOP2023-06-29
07290016880519Pressure Cuff Size 1.6VIASONIX LTDJOP2023-06-29
07290016880526Pressure Cuff Size 7VIASONIX LTDJOP2023-06-29
07290016880472Pressure Cuff Size 12VIASONIX LTDJOP2023-06-25
07290016880465Pressure Cuff Size 10VIASONIX LTDJOP2023-06-23
072900168803974 MHz probe VIASONIX LTDJOP2022-08-08
072900168804038 MHz probe VIASONIX LTDJOP2022-08-08
0729001688041010 MHz probe VIASONIX LTDJOP2022-08-08
008167870243193.9MHz Pencil Probe 7 Foot ODU connectorPARKS MEDICAL ELECTRONICS, INC.JOP2022-05-15
008167870243268.1MHz Pencil Probe 7 Foot ODU connectorPARKS MEDICAL ELECTRONICS, INC.JOP2022-05-15
008167870243338.3MHz Pencil Probe 7 Foot ODU connectorPARKS MEDICAL ELECTRONICS, INC.JOP2022-05-15