NexFoam

GUDID 00858439001606

The Hemostasis NexFoam topical hemostat sponge 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

• Primary Device ID: 00858439001606
• NIH Device Record Key: 73e1df45-0a95-409a-86c7-bdb3bf2a43c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NexFoam
• Version Model Number: 9110254
• 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
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com
• Phone: +1 651-855-1466
• Email: customerservice@hemostasisllc.com

Device Dimensions

• Length: 1.9 Inch
• Width: 0.6 Inch
• Length: 1.9 Inch
• Width: 0.6 Inch
• Length: 1.9 Inch
• Width: 0.6 Inch
• Length: 1.9 Inch
• Width: 0.6 Inch
• Length: 1.9 Inch
• Width: 0.6 Inch
• Length: 1.9 Inch
• Width: 0.6 Inch
• Length: 1.9 Inch
• Width: 0.6 Inch
• Length: 1.9 Inch
• Width: 0.6 Inch
• Length: 1.9 Inch
• Width: 0.6 Inch
• Length: 1.9 Inch
• Width: 0.6 Inch
• Length: 1.9 Inch
• Width: 0.6 Inch
• Length: 1.9 Inch
• Width: 0.6 Inch
• Length: 1.9 Inch
• Width: 0.6 Inch
• Length: 1.9 Inch
• Width: 0.6 Inch

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	00858439001453 [Primary]
GS1	00858439001606 [Package]; Contains: 00858439001453; 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: 2020-10-08 The Hemostasis NexStat topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharides. Th