| Primary Device ID | 00841983103124 |
| NIH Device Record Key | d68054f8-2e04-427d-bc70-432d8a4a6784 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | JE-912AK |
| Catalog Number | JE-912AK |
| Company DUNS | 021063219 |
| Company Name | NIHON KOHDEN AMERICA, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| 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 |
| Phone | +1(800)325-0283 |
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| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841983103124 [Primary] |
| OLV | Standard polysomnograph with electroencephalograph |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-22 |
| 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 |