Cetro America US Transducer for IM76/AM66

GUDID 00852519007007

Replacement ultrasound transducer for Advanced Medical Systems IM76/AM66 model fetal monitor.

CETRO AMERICA INC

Cardiotocograph

• Primary Device ID: 00852519007007
• NIH Device Record Key: 88599900-6b83-44c8-bba3-d0026d186f4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cetro America US Transducer for IM76/AM66
• Version Model Number: 8031010
• 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	00852519007007 [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

• 00852519007250 - Cetro America Toco Transducer for IM76/AM66: 2020-10-02 Replacement Toco Transducer for Advanced Medical Systems/Spacelabs Medical model IM76/AM66 fetal monitors.
• 00852519007267 - Cetro America Toco Transducer for IM77/AM67: 2020-10-02 Replacement Toco Transducer for Advanced Medical Systems/Spacelabs Medical model IM77/AM67 fetal monitors.
• 00852519007274 - Cetro America Toco Transducer for HP 1350+: 2020-10-02 Replacement Toco Transducer for HP/Philips model HP1350+ fetal monitors.
• 00852519007281 - Cetro America Toco Transducer for all Coro models: 2020-10-02 Replacement Toco Transducer for all models of Corometrics brand fetal monitors.
• 00852519007298 - Cetro America Toco Transducer for FC, FS, Fetacare: 2020-10-02 Replacement Toco Transducer for FC, FS, Fetacare
• 00852519007304 - Cetro America Toco Transducer for IM76/AM66, Waterproof: 2020-10-02 Replacement Waterproof Toco Transducer for Advanced Medical Systems/Spacelabs Medical model IM76/AM66 fetal monitors.
• 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.