FDA.reportPublic FDA data

DOPPLEX

Primary DI
05051968017642
Brand
DOPPLEX
Company
HUNTLEIGH HEALTHCARE LIMITED
Model
DFK1-USA-MD2-P
Catalog number
DFK1-USA-MD2-P
Device description
DIA FOOT KIT-USA MULTI DOPLX PLUS
Published
2016-08-25
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
KNGMonitor, Ultrasonic, Fetal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNGMonitor, Ultrasonic, FetalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K930200000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K930200000MULTI DOPPLEX II / FETAL DOPPLEX IIHuntleigh Healthcare, Inc.1994-06-24KNG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051968017642PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051968017642050519680176425051968017642

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive vascular ultrasound system, battery-poweredA hand-held, battery-powered device assembly consisting of a graphical display unit and an attached probe or interchangeable probes, designed to noninvasively locate and assess the extent of vascular flow restriction (e.g., clots, stenosis, mechanical damage) by measuring blood flow rate using ultrasound/Doppler/transit time technology. Clinical applications include venous/arterial flow screening (e.g., assessment of air embolism, atherosclerosis, varicose veins, venous thrombosis, and the vascular states of partially severed extremities), ankle pressure index, and/or blood flow wave form recording.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure860 millibar1060 millibar
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Storage Environment Atmospheric Pressure860 millibar1060 millibar
Storage Environment Humidity0 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4402920485885sales@huntleigh-diagnostics.co
+4402920485885sales@huntleigh-diagnostics.co.uk

Regulatory Flags#

DUNS number
217207083
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05051968014030DOPPLEXACC7ACC7 2016-09-19
05051968032713SONICAIDACC-MI1136ACC-MI1136 2016-09-19
05051968019172DOPPLEXFD1+-PFD1+-P-USA2016-08-22
05051968048233SONICAIDTEAM3A-B3-USATEAM3A-B3-USA2025-12-10
05051968048240SONICAIDTEAM3A-MB3-USATEAM3A-MB3-USA2025-12-10
05051968048257SONICAIDTEAM3A-NB3-USATEAM3A-NB3-USA2025-12-10
05051968048264SONICAIDTEAM3A-NMB3-USATEAM3A-NMB3-USA2025-12-10
05051968048271SONICAIDTEAM3A-NZB3-USATEAM3A-NZB3-USA2025-12-10
05051968048288SONICAIDTEAM3A-ZB3-USATEAM3A-ZB3-USA2025-12-10
05051968048295OBIXOBIX_A3OBIX_A32025-12-10
05051968048301OBIXOBIX_A3_BOBIX_A3_B2025-12-10
05051968048318OBIXOBIX_AN3_BOBIX_AN3_B2025-12-10
05051968048325OBIXOBIX_ANM3OBIX_ANM32025-12-10
05051968048332OBIXOBIX_ANM3_BOBIX_ANM3_B2025-12-10
05051968048349OBIXOBIX_AN3_ZOBIX_AN3_Z2025-12-10
05051968048356OBIXOBIX_AN3_Z_BOBIX_AN3_Z_B2025-12-10
05051968048363OBIXOBIX_INM3-BIOOBIX_INM3-BIO2025-12-10
05051968048370OBIXOBIX_INM3B-BIOOBIX_INM3B-BIO2025-12-10
05051968048387OBIXOBIX_INM3OBIX_INM32025-12-10
05051968048394OBIXOBIX_INM3_BOBIX_INM3_B2025-12-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850067960003Imex 5MHZ DOPPLER PROBE, PD2IMEX, LLCKNG2026-05-18
00850067960027Imex 8MHZ DOPPLER PROBE, PD2IMEX, LLCKNG2026-05-18
00850067960034Imex 3MHZ DOPPLER PROBE,PD2IMEX, LLCKNG2026-05-18
00850067960058Imex DOPPLER PROBE, 2MHZ, H2O PROOF PDIIIMEX, LLCKNG2026-05-18
00850067960041Imex 2MHZ Doppler Probe PD2IMEX, LLCKNG2026-05-13
00860011754510Imex Pocket Dop II Doppler SystemIMEX, LLCKNG2026-05-13
05051968013439DOPPLEXHUNTLEIGH HEALTHCARE LIMITEDKNG2025-12-04
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