| Primary Device ID | 00841983103865 |
| NIH Device Record Key | be814da7-30eb-4341-8323-8e4fea0dd0cc |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | DH-350P |
| Catalog Number | DH-350P |
| Company DUNS | 690568050 |
| Company Name | NIHON KOHDEN CORPORATION |
| 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 | 00841983103865 [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 |
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| 04931921010235 - cap-ONE | 2023-05-30 cap-ONE Nasal Adapter, Adult |
| 04931921010273 - cap-ONE | 2023-05-30 cap-ONE Nasal Adapter, Adult, w/ Oxygen tube |