IMDK

GUDID 06973912940051

Ultrasonic Doppler Fetal Heart Rate Detector

IMDK

Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system Foetal Doppler system

• Primary Device ID: 06973912940051
• NIH Device Record Key: 57b3cc8b-5d88-4369-86a8-d3ee5234eea5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMDK
• Version Model Number: YM-2T8
• Company DUNS: 544547964
• Company Name: IMDK
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973912940051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180419

FDA Product Code

• KNG: Monitor, Ultrasonic, Fetal

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: 2022-05-24
• Device Publish Date: 2022-05-16

On-Brand Devices [IMDK]

• 06973912940075: Fingertip Pulse Oximeter
• 06973912940068: Fingertip Pulse Oximeter
• 06973912940051: Ultrasonic Doppler Fetal Heart Rate Detector
• 06973912940044: Fingertip Pulse Oximeter
• 06973912940037: Fingertip Pulse Oximeter
• 06973912940020: Ultrasonic Doppler Fetal Heart Rate Detector
• 06973912940013: Fingertip Pulse Oximeter