| Primary Device ID | 00852519007281 |
| NIH Device Record Key | 5a140a57-c51d-4155-9757-5b32f88b4915 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cetro America Toco Transducer for all Coro models |
| Version Model Number | 8032010 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00852519007281 [Primary] |
| HGM | System, Monitoring, Perinatal |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-02 |
| Device Publish Date | 2020-09-24 |
| 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 | 2020-10-02Replacement Toco Transducer for all models of Corometrics brand 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. |