| Primary Device ID | 06937683443128 |
| NIH Device Record Key | aa8befc6-5609-4e5f-a5ea-4f2d2f9af544 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Doppler Fetal Heart Rate Detector |
| Version Model Number | FM-200 |
| Company DUNS | 529081176 |
| Company Name | Shenzhen Biocare Bio-Medical Equipment Co., Ltd. |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06937683443128 [Primary] |
| GS1 | 06937683490009 [Package] Package: [1 Units] In Commercial Distribution |
| KNG | Monitor, Ultrasonic, Fetal |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-10-18 |
| 06937683411448 - Digital Electrocardiograph | 2018-07-06 |
| 06937683411530 - Digital Electrocardiograph | 2018-07-06 |
| 06937683412346 - Digital Electrocardiograph | 2018-07-06 |
| 06937683412377 - Digital Electrocardiograph | 2018-07-06 |
| 06937683412520 - Digital Electrocardiograph | 2018-07-06 |
| 06937683413022 - Digital Electrocardiograph | 2018-07-06 |
| 06937683413329 - Digital Electrocardiograph | 2018-07-06 |
| 06937683413879 - Digital Electrocardiograph | 2018-07-06 |