FDA.reportPublic FDA data

DigiDop

Primary DI
00852785008395
Brand
DigiDop
Company
NEWMAN MEDICAL LLC
Model
DD-770-D3W
Catalog number
DD-770-D3W
Device description
DD-II 770 Display Digital Doppler, 3MHz waterproof obstetrical probe
Published
2021-06-25
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
LXEDoppler, Fetal, Ultrasound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
00852785008395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852785008395008527850083958527850083950852785008395

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
00810184540472Meduloc Intramedullary Fracture Fixation (IFF) SystemMEDULOC, LLCLXE2026-01-14
03662200012954NOVAESOC ETUDES RECHERCHES FABRICATIONLXE2022-12-09
00852785008258DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008265DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008272DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008302DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008319DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008326DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008333DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008364DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008371DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008388DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008425DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008432DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008449DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008456DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008487DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008494DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008531DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008548DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008555DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008562DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008807DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008814DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008821DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008838DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008876DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008883DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008890DigiDopNEWMAN MEDICAL LLCLXE2021-06-25
00852785008906DigiDopNEWMAN MEDICAL LLCLXE2021-06-25