FDA.reportPublic FDA data

NexFoam

Primary DI
00858439001453
Brand
NexFoam
Company
HEMOSTASIS, LLC
Model
9110254
Device description
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.
Published
2020-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102459000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102459000NEXSTAT (TM) TOPICAL HEMOSTAT POWDER; NEXFOAM (R) TOPICAL SPONGEHemostasis, LLC2010-12-03QSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858439001606PackageGS15In Commercial Distribution
00858439001453PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858439001606008584390016068584390016060858439001606
00858439001453008584390014538584390014530858439001453

GMDN Terms#

Term, Definition table
TermDefinition
Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobialA non-bioabsorbable device derived from plant polysaccharides [e.g., micro-dispersed oxidized cellulose (M-Doc), oxidized regenerated cellulose (ORC), calcium alginate] intended for topical application to a traumatic wound (e.g., abrasion, laceration, cut), ulcer, and/or surgical wound, to facilitate local haemostasis; it does not contain an antimicrobial agent. It is available in various forms (e.g., gel, spray, powder, ointment, plaster/gauze pad, fibre/wool) that can be applied directly to the wound where it forms a seal until removed. The device is intended for use in the home or healthcare facility. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1.9Inch
Width0.6Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature

Contacts#

Phone, Email table
PhoneEmail
+1 651-855-1466customerservice@hemostasisllc.com

Regulatory Flags#

DUNS number
801380697
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858439001552BoneSeal 2x2.5 gram Ingot95500742019-05-06
00858439001699ExcelArrest XT 2x2 Hemostatic Patch92102232020-11-20
00858439001774AeroClear97700132020-11-30
00858439001279PosiSep X 0.5 x 1.5 Hemostatic Dressing/Intranasal Splint92105642020-02-20
00858439001309PosiSep 0.6 x 2.0 Hemostatic Dressing/Intranasal Splint92105742020-02-20
00858439001330PosiSep X 0.6 x 2.0 Hemostatic Dressing/Intranasal Splint92105842020-02-20
00858439001361PosiSep X 8.0 cm x 1.8 cm Hemostatic Dressing/Intranasal Splint92106042020-02-20
00858439001385PosiSep C92107542020-02-20
00858439001415PosiSep C²92107642020-02-20
00858439001675PosiSep C 0.6 x 2.092108542020-09-30
00858439001903"PosiSep X2 0.8"" x 2.3"""92106152021-05-03
00858439001880"PosiSep X2 0.7"" x 1.7"""92106142021-05-03
00858439001248PosiSep 0.5 x 1.5 Hemostatic Dressing/Intranasal Splint92105542020-02-20
00858439001972NexStat 1gm91301542021-05-03
00858439001910PosiSep X2 0.8" x 2.3"92106152021-05-03
00858439001989NexStat 1gm91301542021-05-03
00858439001613NexPak91105242020-09-30
00858439001637NexPak X91105342020-09-30
00858439001705ExcelArrest XT 2x2 Hemostatic Patch92102232020-11-20
00858439001262NexStat Plus 2gm94300142020-09-30

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