| Primary Device ID | 20817584013371 |
| NIH Device Record Key | 2c86a165-b5c1-4e98-8f0d-ca856e2e418a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fenestrated NeoDrape |
| Version Model Number | ND-FS |
| Catalog Number | ND-FS |
| Company DUNS | 799772079 |
| Company Name | NEOMED, INC. |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10817584013374 [Primary] |
| GS1 | 20817584013371 [Package] Contains: 10817584013374 Package: Case [40 Units] In Commercial Distribution |
| FME | Gown, Examination |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2021-02-05 |
| Device Publish Date | 2020-05-19 |
| 10817584013336 - NeoDrape | 2021-02-05 NeoDrape |
| 20817584013371 - Fenestrated NeoDrape | 2021-02-05Fenestrated NeoDrape |
| 20817584013371 - Fenestrated NeoDrape | 2021-02-05 Fenestrated NeoDrape |
| 00817584013384 - NeoConnect Press-in Bottle Adapter | 2020-09-30 NeoMed NeoConnect Press-in Bottle Adapter, Size E |
| 10817584013404 - NeoConnect Press-in Bottle Adapter | 2020-09-30 NeoMed NeoConnect Press-in Bottle Adapter, Size D |
| 20817584013203 - NeoConnect Oral / Enteral Syringe, OTC | 2020-01-22 3mL NeoConnect Enteral Syringe with ENFit Connector, Non-Sterile, OTC |
| 20817584013210 - NeoConnect Oral / Enteral Syringe, OTC | 2020-01-22 6mL NeoConnect Enteral Syringe with ENFit Connector, Non-Sterile, OTC |
| 20817584013227 - NeoConnect Oral / Enteral Syringe, OTC | 2020-01-22 12mL NeoConnect Enteral Syringe with ENFit Connector, Non-Sterile, OTC |
| 10817584013237 - NeoConnect Oral / Enteral Syringe, OTC | 2020-01-22 60mL NeoConnect Enteral Syringe with ENFit Connector, Non-Sterile, OTC |