DigiDop D2W

GUDID 00852785008548

2MHz waterproof obstetrical probe (probe only)

NEWMAN MEDICAL LLC

Foetal Doppler system probe

• Primary Device ID: 00852785008548
• NIH Device Record Key: b9a8ca41-23b5-4b06-9346-0b9707f4f53d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DigiDop
• Version Model Number: D2W
• Catalog Number: D2W
• Company DUNS: 078686903
• Company Name: NEWMAN MEDICAL LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com
• Phone: 303-974-7689
• Email: info@newman-medical.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852785008548 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090465

FDA Product Code

• LXE: Doppler, Fetal, Ultrasound

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-05
• Device Publish Date: 2021-06-25

On-Brand Devices [DigiDop]

• 00852785008234: DigiDop 701, Display w recharger, 8MHZ VASCULAR
• 00852785008227: DigiDop 701, Display w recharger, 5MHZ VASCULAR
• 00852785008210: DigiDop 701, Display w recharger, 3MHZ OB WATERPROOF
• 00852785008203: DigiDop 701, Display w recharger, 3MHZ OB
• 00852785008197: DigiDop 701, Display w recharger, 2MHZ OB WATERPROOF
• 00852785008180: DigiDop 701, Display w recharger, 2MHZ OB
• 00852785008173: DigiDop 700, Display, 8MHZ VASCULAR
• 00852785008166: DigiDop 700, Display, 5MHZ VASCULAR
• 00852785008159: DigiDop 700, Display, 3MHZ OB WATERPROOF
• 00852785008142: DigiDop 700, Display, 3MHZ OB
• 00852785008135: DigiDop 700, Display, 2MHZ OB WATERPROOF
• 00852785008128: DigiDop 700, Display, 2MHZ OB
• 00852785008111: DigiDop 301, non-display w recharger, 8MHZ VASCULAR
• 00852785008104: DigiDop 301, non-display w recharger, 5MHZ VASCULAR
• 00852785008098: DigiDop 301, non-display w recharger, 3MHZ OB WATERPROOF
• 00852785008081: DigiDop 301, non-display w recharger, 3MHZ OB
• 00852785008074: DigiDop 301, non-display w recharger, 2MHZ OB WATERPROOF
• 00852785008067: DigiDop 301, non-display w recharger, 2MHZ OB
• 00852785008050: DigiDop 300, non-display, 8MHZ VASCULAR
• 00852785008043: DigiDop 300, non-display, 5MHZ VASCULAR
• 00852785008036: DigiDop 300, non-display, 3MHZ OB WATERPROOF
• 00852785008029: DigiDop 300, non-display, 3MHZ OB
• 00852785008012: DigiDop 300, non-display, 2MHZ OB WATERPROOF
• 00852785008005: DigiDop 300, non-display, 2MHZ OB
• 00852785008869: DigiDop 300 non-display Doppler (main unit only)
• 00852785008241: DD-II 330 Non-Display Doppler, 2MHz obstetrical probe
• 00852785008982: DigiDop 901, Table Top Doppler (main unit only)
• 00852785008975: DD-II 770R Display Digital Doppler with recharger (main unit only)
• 00852785008968: DD-II 770AR Display Digital Doppler with recharger and audio recorder (main unit only)
• 00852785008951: DD-II 770A Display Digital Doppler with audio recorder (main unit only)
• 00852785008944: DD-II 770 Display Digital Doppler (main unit only)
• 00852785008937: DD-II 330R Non-display Doppler with recharger (main unit only)
• 00852785008920: DD-II 330AR Non-Display Doppler with recharger and audio recorder (main unit only)
• 00852785008913: DD-II 330A Non-Display Doppler with audio recorder (main unit only)
• 00852785008906: DD-II 330 Non-Display Doppler (main unit only)
• 00852785008890: DigiDop 701 Display Digital Doppler with recharger (main unit only)
• 00852785008883: DigiDop 700 Display Digital Doppler (main unit only)
• 00852785008876: DigiDop 301 non-display Doppler with recharger (main unit only)
• 00852785008852: DigiDop 901, Table Top Doppler, 8MHZ VASCULAR
• 00852785008845: DigiDop 901, Table Top Doppler, 5MHZ VASCULAR
• 00852785008838: DigiDop 901, Table Top Doppler, 3MHZ OB WATERPROOF
• 00852785008821: DigiDop 901, Table Top Doppler, 3MHZ OB
• 00852785008814: DigiDop 901, Table Top Doppler, 2MHZ OB WATERPROOF
• 00852785008807: DigiDop 901, Table Top Doppler, 2MHZ OB
• 00852785008593: Audio PPG vascular probe (probe only)
• 00852785008586: 8MHz vascular probe (probe only)
• 00852785008579: 5MHz vascular probe (probe only)
• 00852785008562: 3MHz waterproof obstetrical probe (probe only)
• 00852785008555: 3MHz obstetrical probe (probe only)
• 00852785008548: 2MHz waterproof obstetrical probe (probe only)