FDA.reportPublic FDA data

SONICAID

Primary DI
05051968008237
Brand
SONICAID
Company
HUNTLEIGH HEALTHCARE LIMITED
Model
8400-6919
Catalog number
8400-6919
Device description
1.5Mhz ULTRASOUND TRANSDUCER
Published
2016-09-12
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
HGMSystem, Monitoring, Perinatal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGMSystem, Monitoring, PerinatalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K912639000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K912639000SONICAID TEAMOxford Medilog, Inc.1991-12-31HGM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051968008237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051968008237050519680082375051968008237

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure680 millibar1060 millibar
Storage Environment Humidity10 Percent (%) Relative Humidity100 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 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
B153300010AirStrip ONE PlatformAirstrip Technologies, Inc.HGM2026-03-18
B153301010AirStrip ONE Client iOSAirstrip Technologies, Inc.HGM2026-03-18
B153301020AirStrip ONE Client AndroidAirstrip Technologies, Inc.HGM2026-03-18
05051968048233SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048240SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048257SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048264SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048271SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048288SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048295OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048301OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048318OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048325OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048332OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048349OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048356OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048363OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048370OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048387OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048394OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048400OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048417OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048424OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048431OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
06944413814714Trolley(For medical use)Edan Instruments, Inc.HGM2025-12-09
06944413819726Trolley(For medical use)Edan Instruments, Inc.HGM2025-12-09
06944413819733Trolley(For medical use)Edan Instruments, Inc.HGM2025-12-09
06944413807112Remote Event MarkerEdan Instruments, Inc.HGM2025-11-29
00860003483565PeriWatch SurveillancePERIGEN INC.HGM2025-11-24
00198953043271CareIntellect PerinatalGe Medical Systems Information Technologies, Inc.HGM2025-11-21