| Primary Device ID | 00858439001477 |
| NIH Device Record Key | a3fa4ee4-af8a-49f7-9087-12326504d172 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BleedArrest ER |
| Version Model Number | 9110264 |
| Company DUNS | 801380697 |
| Company Name | HEMOSTASIS, LLC |
| Device Count | 1 |
| 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 | 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 |
| Phone | +1 651-855-1466 |
| customerservice@hemostasisllc.com |
| Length | 3.8 Centimeter |
| Special Storage Condition, Specify | Between 0 and 0 *BleedArrest ER Topical Hemostat Sponge should be stored at room temperature. Once product package is opened, contents may be subject to contamination. Discard any unused product after opening. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858439001460 [Primary] |
| GS1 | 00858439001477 [Package] Contains: 00858439001460 Package: Carton [5 Units] In Commercial Distribution |
| GS1 | 00858439001484 [Package] Contains: 00858439001460 Package: Carton [10 Units] In Commercial Distribution |
| FRO | Dressing, Wound, Drug |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-02-28 |
| Device Publish Date | 2020-02-20 |
| 00858439001880 - PosiSep X2 0.7" x 1.7" | 2021-05-11 PosiSep X2 devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X2 devices e |
| 00858439001910 - PosiSep X2 0.8" x 2.3" | 2021-05-11 PosiSep X2 devices are patient-comfortable sponges manufactured from naturally occurring Chitosan polymers. PosiSep X2 devices e |
| 00858439001989 - NexStat 1gm | 2021-05-11 The Hemostasis NexStat topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharides. Th |
| 00858439001774 - AeroClear | 2020-12-08 The kit includes the aerosol evacuator that has a white suction connector attached to tubing that terminates in a beveled end. I |
| 00858439001705 - ExcelArrest XT 2x2 Hemostatic Patch | 2020-11-30 ExcelArrest XT (EAXT) is a single use, sterile, dry chitosan-based foam hemostat. EAXT is offered as compressed foam pads in ste |
| 00858439001293 - NexStat Plus 2gm | 2020-10-08 The Hemostasis NexStat Plus topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharide |
| 00858439001408 - NexStat Plus 3gm | 2020-10-08 The hemostasis NexStat Plus topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharide |
| 00858439001439 - NexStat | 2020-10-08 The Hemostasis NexStat topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharides. Th |