| Primary Device ID | 00893257001643 |
| NIH Device Record Key | a696c1af-4f31-4c1f-985c-fabef70f8871 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NitraCare 100 |
| Version Model Number | MNE5055 |
| Catalog Number | MNE5055 |
| Company DUNS | 015809044 |
| Company Name | Medgluv Inc. |
| Device Count | 95 |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | +1(866)633-4588 |
| sales@medgluv.com | |
| Phone | +1(866)633-4588 |
| sales@medgluv.com | |
| Phone | +1(866)633-4588 |
| sales@medgluv.com | |
| Phone | +1(866)633-4588 |
| sales@medgluv.com | |
| Phone | +1(866)633-4588 |
| sales@medgluv.com | |
| Phone | +1(866)633-4588 |
| sales@medgluv.com | |
| Phone | +1(866)633-4588 |
| sales@medgluv.com | |
| Phone | +1(866)633-4588 |
| sales@medgluv.com | |
| Phone | +1(866)633-4588 |
| sales@medgluv.com | |
| Phone | +1(866)633-4588 |
| sales@medgluv.com | |
| Phone | +1(866)633-4588 |
| sales@medgluv.com | |
| Phone | +1(866)633-4588 |
| sales@medgluv.com | |
| Phone | +1(866)633-4588 |
| sales@medgluv.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810145951491 [Unit of Use] |
| GS1 | 00893257001148 [Primary] |
| GS1 | 00893257001643 [Package] Contains: 00893257001148 Package: 90/bx, 10bx/cs [10 Units] In Commercial Distribution |
| QDO | Fentanyl and other opioid protection glove |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-08 |
| Device Publish Date | 2023-10-31 |
| 00893257001643 | NitraCare 100 Nitrile Exam Gloves, Extra Large |
| 00893257001636 | NitraCare 100 Nitrile Exam Gloves, Large |
| 00893257001629 | NitraCare 100 Nitrile Exam Gloves, Medium |
| 00893257001612 | NitraCare 100 Nitrile Exam Gloves, Small |
| 00893257001605 | NitraCare 100 Nitrile Exam Gloves, Extra Small |