DigiDop

Basic Information

• Brand Name: DigiDop
• Primary DI: 00852785008906
• Version / Model: DD-330
• Catalog Number: DD-330
• Company Name: NEWMAN MEDICAL LLC
• Labeler DUNS: 078686903
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-25
• Public Version: 2
• Public Version Date: 2023-11-03
• Public Version Status: Update
• Public Device Record Key: f4b0d48e-269f-4f6d-b5e9-8b26482aa3e4

Device Description

DD-II 330 Non-Display Doppler (main unit only)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXE	Doppler, Fetal, Ultrasound	Obstetrics/Gynecology	884.2660	2
JAF	Monitor, Ultrasonic, Nonfetal	Radiology	892.1540	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34040	Foetal Doppler system	A 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.	No	Active
44311	Noninvasive vascular ultrasound system	An electrically-powered device assembly consisting of a control unit and an attached probe or interchangeable probes, designed to noninvasively locate and assess the extent of vascular (venous and arterial) flow restriction (e.g., clots, stenosis, mechanical damage) by measuring blood flow rate using ultrasound/Doppler/transit time technology. It may also be used to detect the foetal heartbeat.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852785008906	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K090465	000

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 5 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius