Cetro America Ultrasound Transducer for HP1350+

GUDID 00852519007243

Replacement ultrasound transducer for HP1350 and all subsequent Philips models.

CETRO AMERICA INC

Cardiotocograph

• Primary Device ID: 00852519007243
• NIH Device Record Key: d976de19-6f11-4e4e-bc2f-77b4b9877122
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cetro America Ultrasound Transducer for HP1350+
• Version Model Number: 8031012
• Company DUNS: 196275197
• Company Name: CETRO AMERICA 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 12032940121
• Email: admin@cetroamerica.com
• Phone: 12032940121
• Email: admin@cetroamerica.com
• Phone: 12032940121
• Email: admin@cetroamerica.com
• Phone: 12032940121
• Email: admin@cetroamerica.com
• Phone: 12032940121
• Email: admin@cetroamerica.com
• Phone: 12032940121
• Email: admin@cetroamerica.com
• Phone: 12032940121
• Email: admin@cetroamerica.com
• Phone: 12032940121
• Email: admin@cetroamerica.com
• Phone: 12032940121
• Email: admin@cetroamerica.com
• Phone: 12032940121
• Email: admin@cetroamerica.com
• Phone: 12032940121
• Email: admin@cetroamerica.com
• Phone: 12032940121
• Email: admin@cetroamerica.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852519007243 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050826

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by CETRO AMERICA INC

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• 00852519007311 - Cetro America Toco Transducer for IM77/AM67, Waterproof: 2020-10-02 Replacement Waterproof Toco Transducer for Advanced Medical Systems/Spacelabs Medical model IM77/AM67 fetal monitors.
• 00852519007328 - Cetro America Toco Transducer for HP 1350+, Waterproof: 2020-10-02 Replacement Waterproof Toco Transducer for HP/Philips model HP1350+ fetal monitors.