CONTEC

GUDID 06945040100157

Pocket Fetal Doppler

Contec Medical Systems Co., Ltd.

Foetal Doppler system probe

• Primary Device ID: 06945040100157
• NIH Device Record Key: 3b6f7984-a40b-4ccc-8131-512a45603549
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONTEC
• Version Model Number: Baby Sound B
• Company DUNS: 529606295
• Company Name: Contec Medical Systems Co., Ltd.
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06945040100157 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082480

FDA Product Code

• KNG: Monitor, Ultrasonic, Fetal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-29
• Device Publish Date: 2016-09-24

On-Brand Devices [CONTEC]

• 06945040104650: Oxygen Concentrator
• 06945040104643: Pulse Oximeter
• 06945040104636: Pulse Oximeter
• 06945040104629: Pulse Qximeter
• 06945040104612: Pocket Fetal Doppler
• 06945040104605: Pulse Oximeter
• 06945040104599: Pulse Oximter
• 06945040104582: Pulse OXimeter
• 06945040104575: Pulse Oximeter
• 06945040104568: Pulse Oximter
• 06945040104551: Pulse Oximeter
• 06945040104544: Pulse Oximeter
• 06945040104537: Pulse Oximeter
• 06945040104520: Pulse Oximeter
• 06945040104513: Pulse Oximeter
• 06945040104506: Pulse Oximeter
• 06945040104421: Portable ECG Monitor
• 06945040103981: Pulse Oximeter
• 06945040103462: Electrocardiograph
• 06945040101604: Pulse Oximeter
• 06945040101598: Pulse Oximeter
• 06945040101581: Pulse Oximeter
• 06945040101574: Pulse Oximeter
• 06945040101567: Pulse Oximeter
• 06945040101505: Portable ECG Monitor
• 06945040101499: Dynamic ECG Systems
• 06945040101468: Wearable SpO2/ECG Monitor
• 06945040101437: Pulse Oximeter
• 06945040101406: Dynamic ECG Systems
• 06945040101369: urine analyzer
• 06945040101161: B-Ultrasound Diagnostic System
• 06945040100829: Pulse Oximeter
• 06945040100812: Pulse Oximeter
• 06945040100799: Pulse Oximeter
• 06945040100676: Pulse Oximeter
• 06945040100645: Pulse Oximeter
• 06945040100638: Pulse Oximeter
• 06945040100614: Pulse Oximeter
• 06945040100522: Patient Monitor
• 06945040100515: Patient Monitor
• 06945040100492: Electrocardiograph
• 06945040100348: Automatic Blood Pressure Monitor
• 06945040100331: Electronic Sphygmomanometer
• 06945040100324: Electronic Sphygmomanometer
• 06945040100294: Dynamic ECG Systems
• 06945040100287: Pocket Fetal Doppler
• 06945040100270: Pocket Fetal Doppler
• 06945040100232: Pulse Oximeter
• 06945040100225: Pulse Oximeter
• 06945040100218: Pulse Oximeter