Ameritus Transducer ATG-WAVE-UB

GUDID 10817522010816

transducer

KENTEC MEDICAL, INC.

Foetal/maternal prenatal monitor

• Primary Device ID: 10817522010816
• NIH Device Record Key: 49372c2f-6fd9-4b2b-b667-9d2590cfa416
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ameritus Transducer
• Version Model Number: ATG-WAVE-UB
• Catalog Number: ATG-WAVE-UB
• Company DUNS: 066175613
• Company Name: KENTEC MEDICAL, INC.
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 949-863-0810
• Email: kjrooks@kentecmedical.com
• Phone: 949-863-0810
• Email: kjrooks@kentecmedical.com
• Phone: 949-863-0810
• Email: kjrooks@kentecmedical.com
• Phone: 949-863-0810
• Email: kjrooks@kentecmedical.com
• Phone: 949-863-0810
• Email: kjrooks@kentecmedical.com
• Phone: 949-863-0810
• Email: kjrooks@kentecmedical.com
• Phone: 949-863-0810
• Email: kjrooks@kentecmedical.com
• Phone: 949-863-0810
• Email: kjrooks@kentecmedical.com
• Phone: 949-863-0810
• Email: kjrooks@kentecmedical.com
• Phone: 949-863-0810
• Email: kjrooks@kentecmedical.com
• Phone: 949-863-0810
• Email: kjrooks@kentecmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10817522010816 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043075

FDA Product Code

• HGM: System, Monitoring, Perinatal

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: 2022-11-28
• Device Publish Date: 2016-09-21

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