| Primary Device ID | 00817081022681 |
| NIH Device Record Key | d3b0ae51-bdab-4faa-bc25-87d10f31e902 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Disposable Thermoplastic Mouthpiece |
| Version Model Number | Disposable Thermoplastic Mouthpiece - 164900 |
| Catalog Number | 164900 |
| Company DUNS | 020275145 |
| Company Name | A-M SYSTEMS, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | |
| Phone | 3606838300 |
| sales@a-msystems.com | |
| Phone | 3606838300 |
| sales@a-msystems.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817081022674 [Primary] |
| GS1 | 00817081022681 [Package] Contains: 00817081022674 Package: [50 Units] In Commercial Distribution |
| BYP | Mouthpiece, Breathing |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-03-23 |
| Device Publish Date | 2019-10-25 |
| 00817081020816 | Disposable Thermoplastic Mouthpiece |
| 00817081022681 | Disposable Thermoplastic Mouthpiece |