| Primary Device ID | 00817081027228 |
| NIH Device Record Key | 156edc0e-bbdc-45a9-818d-6dbfc3204bbc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PFT Kit F, Disposable, VBMax28E |
| Version Model Number | PFT Kit F - 189188 |
| Catalog Number | 189188 |
| 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 | true |
| 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 |
| 00817081028270 - PFT Kit E, VBMax36E | 2025-03-05 Pulmonary Function Testing Kit E, VBMax36E W/ Foam Nose Clip & 1649, Labeled D R Burton |
| 00817081028294 - Disposable White PFT Nose Clip with Rubber Pads, Labeled D R Burton | 2025-03-05 Disposable White Pulmonary Function Testing Nose Clip with Rubber Pads, Labeled D R Burton |
| 00817081028317 - Disposable Blue PFT Nose Clip with Rubber Pads | 2025-03-05 Disposable Blue Pulmonary Function Testing Nose Clip with Rubber Pads, Labeled D R Burton |
| 00817081028331 - Disposable Blue PFT Nose Clip with Foam Pads | 2025-03-05 Disposable Blue PFT Nose Clip with Foam Pads, Labeled D R Burton |
| 00817081028232 - Mouthpiece, Disposable, White, Thermoplastic, Bite Block Style | 2025-03-03 Mouthpiece, Disposable, White, Thermoplastic, Bite Block Style, D R Burton |
| 00817081028256 - Breathebite Mouthpiece, Disposable, Thermoplastic, Tongue Depressing | 2025-03-03 Breathebite Mouthpiece, Disposable, White, Thermoplastic, Tongue Depressing, D R Burton |
| 00817081028218 - PFT Nose Clip with Foam Pads | 2025-02-28 Disposable White Pulmonary Function Testing Nose Clip with Foam Pads |
| 00817081028195 - Pulmonary Function Test Kit E | 2025-02-26 Pulmonary Function Test Kit E, VBMax35E W/ Foam Nose Clip & 1649, Labeled D R Burton |