| Primary Device ID | 00817081020878 |
| NIH Device Record Key | 90ca3243-6d05-475d-9ff1-eb8f6bf7c71a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VBMax30L |
| Version Model Number | VBMax30L - 156377 |
| Catalog Number | 156377 |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 3606838300 |
| sales@a-msystems.com | |
| Phone | 3606838300 |
| sales@a-msystems.com | |
| Phone | 3606838300 |
| sales@a-msystems.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817081020861 [Primary] |
| GS1 | 00817081020878 [Package] Contains: 00817081020861 Package: [100 Units] In Commercial Distribution |
| CAH | Filter, Bacterial, Breathing-Circuit |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-11-29 |
| 00817081027709 - Pulmonary Function Test Kit B, 33mm VBMAX | 2024-03-25 Pulmonary Function Test Kit B, Disposable, Qty 100, 33 MM O.D. W/ Blue Foam Nose Clip |
| 00817081027723 - PFT KIT A, 31 MM O.D. w/ White Foam Nose Clips | 2024-03-25 Pulmonary Function Test KIT A, 31 MM O.D. w/ White Foam Nose Clips |
| 00817081027686 - Adapter, Tube, Sample Pack | 2023-11-29 Adapter, Tube, Sample Pack, 1134, 1135, 1136, 1138 |
| 00817081027679 - PFT Kit B, 33 MM O.D. W/ White Foam Nose Clip | 2023-10-25 Pulmonary Function Testing Kit B, Disposable, Qty 100, 33 MM O.D. W/ White Foam Nose Clip |
| 00817081027655 - PFT Kit E, VBMax31E, with Rubber Mouthpiece & Noseclip | 2023-10-12 PFT Kit E, VBMax31E, with Rubber Mouthpiece & Noseclip |
| 00817081027624 - PFT Kit G, VBMax 34E | 2023-06-29 Pulmonary Function Test Kit G, Disposable, Qty 100, VBMax34E with Disposable Rubber Mouthpiece |
| 00817081027600 - Personal Best Full Range Peak Flow Meter | 2023-06-15 Personal Best Full Range Peak Flow Meter |
| 00817081027587 - PFT Kit I, VBMax31S | 2023-05-25 Pulmonary Function Test Kit I, VBMax31S, with White Foam Nose Clip & Rubber Mouthpiece |