| Primary Device ID | 00817081028270 |
| NIH Device Record Key | b9282933-6c23-490a-99e7-13d3fce21f23 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PFT Kit E, VBMax36E |
| Version Model Number | PFT Kit E, VBMax36E - 189139 |
| Catalog Number | 189139 |
| 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 | |
| Phone | 3606838300 |
| sales@a-msystems.com | |
| Phone | 3606838300 |
| sales@a-msystems.com | |
| Phone | 3606838300 |
| sales@a-msystems.com | |
| Phone | 3606838300 |
| sales@a-msystems.com | |
| Phone | 3606838300 |
| sales@a-msystems.com | |
| Phone | 3606838300 |
| sales@a-msystems.com | |
| Phone | 3606838300 |
| sales@a-msystems.com | |
| Phone | 3606838300 |
| sales@a-msystems.com | |
| Phone | 3606838300 |
| sales@a-msystems.com | |
| Phone | 3606838300 |
| sales@a-msystems.com | |
| Phone | 3606838300 |
| sales@a-msystems.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817081028263 [Primary] |
| GS1 | 00817081028270 [Package] Contains: 00817081028263 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 | 2025-03-05 |
| Device Publish Date | 2025-02-25 |
| 00817081022629 | PFT Kit E, Disposable, Qty 100, VBMax36E, W/ Blue Foam Nose Clips |
| 00817081028270 | Pulmonary Function Testing Kit E, VBMax36E W/ Foam Nose Clip & 1649, Labeled D R Burton |