NexStat
GUDID 00858439001439
The Hemostasis NexStat topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharides. The hemostatic particles quickly dehydrate blood cells, resulting in hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding.
HEMOSTASIS, LLC
Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial| Primary Device ID | 00858439001439 |
| NIH Device Record Key | 06445fcc-2c58-4ce7-8137-067f715df05c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NexStat |
| Version Model Number | 9130144 |
| 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 |
Customer Support Contacts
| Phone | +1 651-855-1466 |
| customerservice@hemostasisllc.com | |
| Phone | +1 651-855-1466 |
| customerservice@hemostasisllc.com | |
| Phone | +1 651-855-1466 |
| customerservice@hemostasisllc.com | |
| Phone | +1 651-855-1466 |
| customerservice@hemostasisllc.com | |
| Phone | +1 651-855-1466 |
| customerservice@hemostasisllc.com | |
| Phone | +1 651-855-1466 |
| customerservice@hemostasisllc.com | |
| Phone | +1 651-855-1466 |
| customerservice@hemostasisllc.com | |
| Phone | +1 651-855-1466 |
| customerservice@hemostasisllc.com | |
| Phone | +1 651-855-1466 |
| customerservice@hemostasisllc.com | |
| Phone | +1 651-855-1466 |
| customerservice@hemostasisllc.com | |
| Phone | +1 651-855-1466 |
| customerservice@hemostasisllc.com | |
| Phone | +1 651-855-1466 |
| customerservice@hemostasisllc.com | |
| Phone | +1 651-855-1466 |
| customerservice@hemostasisllc.com | |
| Phone | +1 651-855-1466 |
| customerservice@hemostasisllc.com |
Device Dimensions
| Weight | 3 Gram |
| Weight | 3 Gram |
| Weight | 3 Gram |
| Weight | 3 Gram |
| Weight | 3 Gram |
| Weight | 3 Gram |
| Weight | 3 Gram |
| Weight | 3 Gram |
| Weight | 3 Gram |
| Weight | 3 Gram |
| Weight | 3 Gram |
| Weight | 3 Gram |
| Weight | 3 Gram |
| Weight | 3 Gram |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858439001439 [Primary] |
| GS1 | 00858439001446 [Package] Package: Carton [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K102459
FDA Product Code
| FRO | Dressing, Wound, Drug |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-08 |
| Device Publish Date | 2020-09-30 |
Devices Manufactured by HEMOSTASIS, LLC
| 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 | 2020-10-08The Hemostasis NexStat topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharides. The hemostatic particles quickly dehydrate blood cells, resulting in hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding. |
| 00858439001439 - NexStat | 2020-10-08 The Hemostasis NexStat topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharides. Th |
Trademark Results [NexStat]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEXSTAT 86650344 4881322 Live/Registered |
Hemostasis, LLC 2015-06-03 |
 NEXSTAT 77499765 3716261 Dead/Cancelled |
Hemostasis, LLC 2008-06-16 |
 NEXSTAT 76456674 not registered Dead/Abandoned |
NEXCYCLE PLASTICS, INC. 2002-10-08 |
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