FDA.reportPublic FDA data

DigiDop

Primary DI
00852785008548
Brand
DigiDop
Company
NEWMAN MEDICAL LLC
Model
D2W
Catalog number
D2W
Device description
2MHz waterproof obstetrical probe (probe 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
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
00852785008548PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852785008548008527850085488527850085480852785008548

GMDN Terms#

Term, Definition table
TermDefinition
Foetal Doppler system probeA hand-operated component of a foetal Doppler system which is placed on the surface of a pregnant woman's abdomen to detect foetal heart beats using ultrasonic/Doppler technology. It may include single or multiple element transducer configurations that convert electric voltages into an ultrasound beam reproducing movement and flow typically as sound. The device is available in various frequency capacities (e.g., 2 or 3 MHz). This is a reusable device.

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
00852785008395DigiDopNEWMAN 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
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