| Primary Device ID | 00817081021370 |
| NIH Device Record Key | 68d13163-d54e-4cbf-828a-f079723c23e4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VBMax28e |
| Version Model Number | VBMax28E - 146918 |
| Catalog Number | 146918 |
| 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 |
| Phone | 3606838300 |
| sales@a-msystems.com | |
| Phone | 3606838300 |
| sales@a-msystems.com | |
| Phone | 3606838300 |
| sales@a-msystems.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817081021363 [Primary] |
| GS1 | 00817081021370 [Package] Contains: 00817081021363 Package: [400 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 | 2018-07-16 |
| Device Publish Date | 2018-06-13 |
| 00817081027914 - 3 Liter Aluminum Calibration Syringe w/ Adapter | 2024-11-15 3 Liter Aluminum Calibration Syringe w/ Adapter |
| 00817081027884 - PFT Kit A, 28MM O.D | 2024-11-01 Pulmonary Function Test Kit A, 28MM O.D., W/Foam Nose Clip & Rubber Mouthpiece |
| 00817081027907 - PFT Kit J, VBMax36S | 2024-11-01 Pulmonary Function Test Kit J, VBMax36S with Blue Foam Nose Clip |
| 00817081027846 - PFT Kit I, VBMax 34s with Nose Clip and Mouthpiece | 2024-10-16 Pulmonary Function Test Kit I, VBMax34S, w/ Blue Rubber Nose Clips & Rubber Mouthpiece |
| 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 |