| Primary Device ID | 00817081028034 |
| NIH Device Record Key | 23e9f713-a9dc-4f2d-ac7c-fc0212bfa194 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VBMax34E, PF Testing Filter Labeled DR Burton |
| Version Model Number | VBMax34E - 146404 |
| Catalog Number | 146404 |
| Company DUNS | 020275145 |
| Company Name | A-M SYSTEMS, LLC |
| 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 | 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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| 00817081028539 - PFT KIT J, VBMax34S w/ Blue Rubber Nose clip | 2025-07-03 PFT KIT J, VBMax34S w/ Blue Rubber Nose clip |
| 00817081028492 - VBMax34, PF Testing Filter Labeled DR Burton | 2025-06-11 VBMax34, Pulmonary Function Testing Filter Labeled DR Burton |
| 00817081028478 - PFT Kit B, VBMax35 | 2025-05-20 Pulmonary Function Testing Kit B, VBMax35 with Blue Rubber Pad Nose Clip |
| 00817081028454 - PFT Kit J, VBMax31S | 2025-05-12 Pulmonary Function Testing Kit J, VBMax31S with White Rubber Pad Nose Clip |
| 00817081028416 - VBMax28, PF Testing Filter | 2025-04-11 VBMax28, Pulmonary Function Testing Filter Labeled DR Burton |
| 00817081028430 - PFT Kit B, VBMax35 w/ Blue Foam Nose clip | 2025-04-11 Pulmonary Function Test Kit B, VBMax35 w/ Blue Foam Nose clip |
| 00817081028393 - PFT Kit I, VBMax36S w/ Foam Nose Clip and 164900 | 2025-04-10 Pulmonary Function Test Kit I, VBMax36S w/ Foam Nose Clip and 164900, Labeled DR Burton |