| Primary Device ID | 00619498619108 |
| NIH Device Record Key | 85d2988e-9adf-4345-9520-d289ff7e0521 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GECKO NASAL PAD LGE - AMER |
| Version Model Number | 61910 |
| Catalog Number | 61910 |
| Company DUNS | 751149311 |
| Company Name | RESMED PTY LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00619498619108 [Primary] |
| GS1 | 00619498619153 [Package] Package: BOX [10 Units] In Commercial Distribution |
| FMP | Protector, Skin Pressure |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-14 |
| Device Publish Date | 2023-06-06 |
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| 00619498643011 - AirFit X30i | 2024-12-17 AIRFIT X30I STD STPK AMER |
| 00619498643509 - AirFit X30i | 2024-12-17 AirFit X30i LGE STPK AMER |
| 00619498643547 - AirFit X30i | 2024-12-17 AIRFIT X30I SML STPK AMER - SLM |
| 00619498643554 - AirFit X30i | 2024-12-17 AIRFIT X30I STD STPK AMER - SLM |
| 00619498643561 - AirFit X30i | 2024-12-17 AirFit X30i LGE STPK AMER - SLM |
| 00619498623006 - AIRTOUCH N30I | 2024-10-11 AIRTOUCH N30I STD STPK AMER |
| 00619498623013 - AIRTOUCH N30I | 2024-10-11 AIRTOUCH N30I SML STPK AMER |