| Primary Device ID | 10814278020663 |
| NIH Device Record Key | 595223b4-e4a9-49f5-ad57-ac57503f126a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NeuMoDxTM Biohazard Waste Bag |
| Version Model Number | 600100 |
| Catalog Number | 600100 |
| Company DUNS | 078667309 |
| Company Name | Neumodx Molecular, Inc. |
| Device Count | 5 |
| DM Exempt | true |
| 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 | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com | |
| Phone | +1(734)372-2617 |
| ewinnega@neumodx.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814278020666 [Unit of Use] |
| GS1 | 10814278020663 [Primary] |
| PPM | General purpose reagent |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-04-08 |
| Device Publish Date | 2019-03-29 |
| 00814278020864 - NeuMoDx™ Lysis Buffer 5 | 2021-12-22 NeuMoDx™ Lysis Buffer 5 |
| 00814278021304 - NeuMoDx™ Vantage Viral Lysis Buffer | 2021-12-22 NeuMoDx™ Vantage Viral Lysis Buffer |
| 00814278021267 - NeuMoDx SARS-CoV-2 Test Strip | 2020-05-01 |
| 00814278021250 - NeuMoDx™ Viral Lysis Buffer | 2020-03-30 NeuMoDx™ Viral Lysis Buffer |
| 00814278021212 - NeuMoDx™ Lysis Buffer 6 | 2020-03-27 NeuMoDx™ Lysis Buffer 6 |
| 10814278020045 - NeuMoDxTM GBS Test Strip | 2019-04-11 NeuMoDx GBS Test Strip |
| 00814278020000 - NeuMoDxTM 96 Molecular System | 2019-04-08 NeuMoDx 96 Molecular System |
| 10814278020199 - NeuMoDxTM LDT Master Mix, DNA | 2019-04-08 NeuMoDx LDT Master Mix, DNA |