| Primary Device ID | 50085412095832 |
| NIH Device Record Key | 7adb8e1c-8d19-476e-812e-f769e54eba23 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Duploject Easy Prep |
| Version Model Number | 1501250 |
| Catalog Number | 1501250 |
| Company DUNS | 005146311 |
| Company Name | BAXTER INTERNATIONAL INC. |
| 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 | true |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)933-0303 |
| Medinfo_medproducts@baxter.com |
| Total Volume | 2 Milliliter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00085412095837 [Primary] |
| GS1 | 50085412095832 [Package] Contains: 00085412095837 Package: CASE [6 Units] In Commercial Distribution |
| FMF | Syringe, piston |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
| 50085412095849 | Fibrin Sealant Preparation and Application System for the preparation and application of Tisseel |
| 50085412095832 | Fibrin Sealant Preparation and Application System for the preparation and application of Tisseel |
| 50085412095634 | Fibrin Sealant Preparation and Application System for the preparation and application of Tisseel |