FDA.reportPublic FDA data

DigiDop

Primary DI
00852785008906
Brand
DigiDop
Company
NEWMAN MEDICAL LLC
Model
DD-330
Catalog number
DD-330
Device description
DD-II 330 Non-Display Doppler (main unit only)
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
LXEDoppler, Fetal, Ultrasound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAFMonitor, Ultrasonic, NonfetalRadiology2
LXEDoppler, Fetal, UltrasoundObstetrics/Gynecology2

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
00852785008906PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852785008906008527850089068527850089060852785008906

GMDN Terms#

Term, Definition table
TermDefinition
Foetal Doppler systemA portable, hand-held, battery-powered device assembly consisting of a measuring and display unit and an attached probe or interchangeable probes designed to noninvasively detect foetal heart beats using ultrasound/Doppler technology. The heart beats are typically conveyed audibly via the measuring/display unit and attached probe which is applied to the surface of the pregnant woman's abdomen. The device aids in determining foetal viability.

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
00852785008463DigiDopDD-770R-D5DD-770R-D52021-06-25
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

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
00810184540472Meduloc Intramedullary Fracture Fixation (IFF) SystemMEDULOC, LLCLXE2026-01-14
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
03662200012954NOVAESOC ETUDES RECHERCHES FABRICATIONLXE2022-12-09
18033737710781THD SLIDE ONETHD SPAJAF2022-09-09
08033737710777THD SLIDE ONETHD SPAJAF2022-09-01
18033737710774THD SLIDE ONETHD SPAJAF2022-09-01
05051968044501DOPPLEXHUNTLEIGH HEALTHCARE LIMITEDJAF2022-02-07
00852785008258DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008265DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008272DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008289DigiDopNEWMAN MEDICAL LLCJAF2021-06-25
00852785008296DigiDopNEWMAN MEDICAL LLCJAF2021-06-25
00852785008302DigiDopNEWMAN MEDICAL LLCLXE2021-06-25