| Primary Device ID | 04931921113752 |
| NIH Device Record Key | 64f6b072-453b-4855-b301-7713a53d5644 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | DH-350P |
| Catalog Number | DH-350P |
| Company DUNS | 021063219 |
| Company Name | NIHON KOHDEN 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 | false |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04931921113752 [Primary] |
| MHX | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-02-06 |
| Device Publish Date | 2016-09-24 |
| 10841983101493 - NA | 2026-02-09 Airway adapter for TG-900P |
| 10841983101509 - NA | 2026-02-09 Airway adapter for TG-920P |
| 10841983101516 - cap-ONE | 2026-02-09 Nasal adapter for TG-920P (oxygen cannula adjustment) |
| 10841983101523 - NA | 2026-02-09 Airway adapter for adult and child |
| 10841983101530 - NA | 2026-02-09 Airway adapter for neonate and child, TG-970P |
| 10841983101547 - NA | 2026-02-09 Airway adapter for neonate and child |
| 10841983101554 - cap-ONE | 2026-02-09 Cap-ONE Mask, Pediatric |
| 10841983101561 - cap-ONE | 2026-02-09 Cap-ONE Mask, Infant |