| Primary Device ID | 00817081022537 |
| NIH Device Record Key | 52092440-fe8f-4080-bba8-2eacab1b8ecc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VBMax PFT Kit I |
| Version Model Number | VBMax PFT Kit I - 187165 |
| Catalog Number | 187165 |
| 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 |
| Phone | 3606838300 |
| sales@a-msystems.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817081022520 [Primary] |
| GS1 | 00817081022537 [Package] Contains: 00817081022520 Package: [100 Units] In Commercial Distribution |
| CAH | Filter, Bacterial, Breathing-Circuit |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-08-13 |
| Device Publish Date | 2019-08-05 |
| 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 |
| 00817081028379 - PFT Kit B, VBMax48 | 2025-04-01 Pulmonary Function Test Kit B, VBMax48 w/ Rubber Nose clip and Tube Mouthpiece |
| 00817081028355 - Pulmonary Function Test Kit E | 2025-03-10 Pulmonary Function Test Kit E, VBMax34E w/ Foam Nose Clip and Rubber Mouthpiece |
| 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 |