FDA.reportPublic FDA data

DOPPLEX

Primary DI
05051968030504
Brand
DOPPLEX
Company
HUNTLEIGH HEALTHCARE LIMITED
Model
ACC-VAS-026
Catalog number
ACC-VAS-026
Device description
ADULT LEFT ANKLE CUFF
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
JOMPlethysmograph, Photoelectric, Pneumatic Or Hydraulic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOMPlethysmograph, Photoelectric, Pneumatic Or HydraulicCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121108000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121108000DOPPLEX ABILITYHuntleigh Healthcare2013-01-03JOM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051968030504PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051968030504050519680305045051968030504

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 Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure860 millibar1060 millibar
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 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
00860011800613CardioTagCARDIOSENSE, INC.JOM2026-10-14
00862467000333PADnet XpressCollaborative Care Diagnostics, LLCJOM2026-02-04
08690020003017VitalScan ANSMedeia, Inc.JOM2025-02-05
08690020003031VitalScan HRVMedeia, Inc.JOM2025-02-05
B322G0011ANS1 SoftwareLD TECHNOLOGY, LLCJOM2024-03-05
B322H0011LD-EKGLD TECHNOLOGY, LLCJOM2024-03-05
05051968035370DOPPLEXHUNTLEIGH HEALTHCARE LIMITEDJOM2022-10-10
03830059851523MESI mTABLET TBIMESI d.o.o.JOM2022-04-25
03830059850366MESI ABPI MDMESI d.o.o.JOM2021-07-09
03830059851141MESI mTABLET ABIMESI d.o.o.JOM2021-07-09
00884838093188Avalon Toco+ MP TransducerPhilips Medizin Systeme Böblingen GmbHJOM2021-03-08
00884838093195Avalon Ultrasound TransducerPhilips Medizin Systeme Böblingen GmbHJOM2021-03-08
00884838093201Avalon ECG/IUP TransducerPhilips Medizin Systeme Böblingen GmbHJOM2021-03-08
00884838093218Avalon Toco MP TransducerPhilips Medizin Systeme Böblingen GmbHJOM2021-03-08
00884838093225Avalon Toco+ TransducerPhilips Medizin Systeme Böblingen GmbHJOM2021-03-08
00191237000014SA-3000PMedicore Co., Ltd.JOM2019-04-10
10191237000011SA-3000PMedicore Co., Ltd.JOM2019-04-10
00191237000038Max PulseMedicore Co., Ltd.JOM2019-03-05
40191237000036Max PulseMedicore Co., Ltd.JOM2019-03-05
B322C0011TBL-ABILD TECHNOLOGY, LLCJOM2019-01-16
04051526846302MEDIMEDI MANUFACTURING, INC.JOM2018-11-20
04051526846463MEDIMEDI MANUFACTURING, INC.JOM2018-11-20
04051526849631MEDIMEDI MANUFACTURING, INC.JOM2018-11-20
04051526903616MEDIMEDI MANUFACTURING, INC.JOM2018-11-20
00636257188439MEDIMEDI MANUFACTURING, INC.JOM2018-11-20
00636257189085MEDIMEDI MANUFACTURING, INC.JOM2018-11-20
00817065022454HokansonD.E.HOKANSON, INC.JOM2017-12-12
05051968030429DOPPLEXHUNTLEIGH HEALTHCARE LIMITEDJOM2016-11-07
05051968030436DOPPLEXHUNTLEIGH HEALTHCARE LIMITEDJOM2016-11-07
00860446000312APG Air-PlethysmographACI MEDICAL LLCJOM2016-09-24