FDA.reportPublic FDA data

DigiDop

Primary DI
00852785008463
Brand
DigiDop
Company
NEWMAN MEDICAL LLC
Model
DD-770R-D5
Catalog number
DD-770R-D5
Device description
DD-II 770R Display Digital Doppler with recharger, 5MHz vascular probe
Published
2021-06-25
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
JAFMonitor, Ultrasonic, Nonfetal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAFMonitor, Ultrasonic, NonfetalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090465000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090465000DIGDOP ULTRASOUND SYSTEMThe Newman Group, LLC2009-04-08ITX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852785008463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852785008463008527850084638527850084630852785008463

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 Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity5 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
303-974-7689info@newman-medical.com

Regulatory Flags#

DUNS number
078686903
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852785008289DigiDopDD-330-D5DD-330-D52021-06-25
00852785008296DigiDopDD-330-D8DD-330-D82021-06-25
00852785008340DigiDopDD-330R-D5DD-330R-D52021-06-25
00852785008357DigiDopDD-330R-D8DD-330R-D82021-06-25
00852785008401DigiDopDD-770-D5DD-770-D52021-06-25
00852785008418DigiDopDD-770-D8DD-770-D82021-06-25
00852785008470DigiDopDD-770R-D8DD-770R-D82021-06-25
00852785008494DigiDopDD-700-VODD-700-VO2021-06-25
00852785008500DigiDopDD-700-VASCDD-700-VASC2021-06-25
00852785008517DigiDopDD-300-VASCDD-300-VASC2021-06-25
00852785008524DigiDopDD-PADDD-PAD2021-06-25
00852785008579DigiDopD5D52021-06-25
00852785008586DigiDopD8D82021-06-25
00852785008593DigiDopDPPGDPPG2021-06-25
00852785008661simpleABIABI-QABI-Q2021-06-25
00852785008845DigiDopDD-901-D5DD-901-D52021-06-25
00852785008852DigiDopDD-901-D8DD-901-D82021-06-25
00852785008876DigiDopDD-301DD-3012021-06-25
00852785008883DigiDopDD-700DD-7002021-06-25
00852785008890DigiDopDD-701DD-7012021-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850067960010Imex ELITE 3MHZ OB PROBEIMEX, LLCJAF2026-05-18
00860011754565Imex ELITE 2MHZ WATERPROOF PROBE V2IMEX, LLCJAF2026-05-18
00860011754572Imex ELITE 2MHZ OB PROBEIMEX, LLCJAF2026-05-18
00860011754589Imex ELITE 8MHZ VASCULAR PROBEIMEX, LLCJAF2026-05-18
00860011754596Elite 5 MHz Vascular ProbeIMEX, LLCJAF2026-05-18
00860011754503Imex Elite 200 DopplerIMEX, LLCJAF2026-05-13
00860011754527Imex Elite 100 DopplerIMEX, LLCJAF2026-05-13
00860011754534Imex CT+ DopplerIMEX, LLCJAF2026-05-13
00860011754541Imex Elite 200R DopplerIMEX, LLCJAF2026-05-13
00860011754558Imex Elite 100R DopplerIMEX, LLCJAF2026-05-13
08033737710869THD SLIDE ONETHD SPAJAF2025-10-30
18033737710354THD SLIDE ONETHD SPAJAF2025-10-30
08051887047918THD SLIDE ONETHD SPAJAF2025-04-03
18051887047915THD SLIDE ONETHD SPAJAF2025-04-03
B4371194904Unetixs Vascular UNETIXS VASCULAR, INC.JAF2023-02-27
B4371198605Unetixs Vascular UNETIXS VASCULAR, INC.JAF2023-02-27
B4371199606Unetixs Vascular UNETIXS VASCULAR, INC.JAF2023-02-27
B437129500Unetixs Vascular UNETIXS VASCULAR, INC.JAF2023-02-27
18033737710781THD SLIDE ONETHD SPAJAF2022-09-09
08033737710777THD SLIDE ONETHD SPAJAF2022-09-01
18033737710774THD SLIDE ONETHD SPAJAF2022-09-01
05051968044501DOPPLEXHUNTLEIGH HEALTHCARE LIMITEDJAF2022-02-07
00852785008289DigiDopNEWMAN MEDICAL LLCJAF2021-06-25
00852785008296DigiDopNEWMAN MEDICAL LLCJAF2021-06-25
00852785008340DigiDopNEWMAN MEDICAL LLCJAF2021-06-25
00852785008357DigiDopNEWMAN MEDICAL LLCJAF2021-06-25
00852785008401DigiDopNEWMAN MEDICAL LLCJAF2021-06-25
00852785008418DigiDopNEWMAN MEDICAL LLCJAF2021-06-25
00852785008470DigiDopNEWMAN MEDICAL LLCJAF2021-06-25
00852785008494DigiDopNEWMAN MEDICAL LLCJAF2021-06-25