| Primary Device ID | 00817081027044 |
| NIH Device Record Key | d973c8c2-71ec-4a74-b689-145804c26ddd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Breathbite Mouthpiece, Disposable , Tongue Depressing |
| Version Model Number | Breathbite Mouthpiece - 164950 |
| Catalog Number | 164950 |
| Company DUNS | 020275145 |
| Company Name | A-M SYSTEMS, LLC |
| 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 | true |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
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| 00817081027860 - PFT KIT J, VBMax35S, w/ Foam Nose Clip | 2024-10-16 Pulmonary Function Test Kit J, VBMax35S, w/ Foam Nose Clip |
| 00817081027822 - PFT Kit A, 48 MM O.D. | 2024-09-30 PFT Kit A, 48 MM O.D. |
| 00817081027808 - PFT KIT F, VBMax36S w/ Rubber Nose Clips | 2024-09-16 Pulmonary Function Test Kit F, VBMax36S with Rubber Nose Clips |
| 00817081027785 - PFT Kit I, VBMax35S, w/ White Foam Nose Clips | 2024-07-18 Pulmonary Function Test Kit I, VBMax35S, w/ White Foam Nose Clips |