FDA.reportPublic FDA data

DOPPLEX

Primary DI
05051968032317
Brand
DOPPLEX
Company
HUNTLEIGH HEALTHCARE LIMITED
Model
PA8XS
Catalog number
PA8XS
Device description
IOP PROBE ADAPTOR, XS
Published
2021-05-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201425000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201425000Disposable Intraoperative Probe (DIOP8)Huntleigh Healthcare Limited2021-02-19ITX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051968032317PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051968032317050519680323175051968032317

GMDN Terms#

Term, Definition table
TermDefinition
Invasive vascular ultrasound system probeA hand-operated component of an invasive vascular ultrasound system intended to be used perioperatively to measure the flow of blood in an isolated blood vessel, by being applied to the outside of the vessel, using ultrasonic/Doppler/transit time technology. It may also be used for cross-sectional visualization/imaging. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure700 millibar1060 millibar
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00At a relative humidity of up to 90% non condensing: +5 degrees C to +35 degrees C
Special Storage Condition, Specify00At a water vapour pressure up to 50hPa : >+35 degrees C to +70 degrees C
Special Storage Condition, Specify00Without relative humidity control: -25 degrees C to +5 degrees C

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04580826926518PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
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04580826926556PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826927881PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928291PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
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08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
00841517112684C5-1FUJIFILM SONOSITE, INC.ITX2026-08-07
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00841436124294Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436125895Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126052Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126403Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126410Needle Guide BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27