FDA.reportPublic FDA data

StatGuard Hemostatic Patch

Primary DI
30815614020808
Brand
StatGuard Hemostatic Patch
Company
SEMLER TECHNOLOGIES, INC.
Model
3010-00
Catalog number
480-3010-00
Device description
The StatGuard Hemostatic Patch is composed of a non-woven gauze made of chitosan which is applied to an arterial or venous puncture or incision following to promote post-procedure hemostasis and control of moderate to severe wound bleeding, exudates absorption, and coagulation.
Published
2019-08-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug
QSYHemostatic Wound Dressing Without Thrombin Or Other Biologics

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU
QSYHemostatic Wound Dressing Without Thrombin Or Other BiologicsUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172155000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172155000StatGuard Hemostatic Patch, StatGuard Hemostatic DressingStatguard, LLC2018-04-12QSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20815614020801PackageGS120In Commercial Distribution
30815614020808PackageGS110In Commercial Distribution
10815614020804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081561402080120815614020801
3081561402080830815614020808
1081561402080410815614020804

GMDN Terms#

Term, Definition table
TermDefinition
Chitosan haemostatic agent, professionalA non-bioabsorbable device that includes chitosan (a polysaccharide derived from chitin, the structural element in the exoskeleton of crustaceans) as a principal component, intended to be applied exclusively by healthcare professionals in a clinical setting to traumatic wounds in emergency situations (e.g., road accidents, combat, emergency rescue) or during surgical intervention to produce a rapid haemostasis by forming a robust plug of gel which is removed after use. The chitosan may be intended to provide antibacterial activity, and is available in a variety of forms (e.g., fine particles in a pouch, coated on gauze). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
042075700
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10815614020156mBrace Wrist Support with Hook4250140-0250-002022-11-17
10815614020163mBrace Wrist Support with Clip4275140-0275-002022-11-17
10815614020170Wrist Assist Wrist Support4300140-0300-002022-11-17
10815614020262FlexBoard Wrist Support4400140-0400-002022-11-17
10815614020347WristAssist4300M140-0300-00-M2022-11-17
10815614021092mBrace 4285 Wrist Support with Hook4285140-0285-002025-02-27
10815614021085mBrace 4280 Wrist Support4280140-0280-002024-02-01
10815614020125mBrace Wrist Support4200140-0200-002022-11-15
10815614021115Elevate ArmBoard Extender H8100-EXTH180-0100-EXTH2025-05-19
10815614021122Elevate ArmBoard Extender H 8100-EXTH-U180-0100-EXTH-U2025-05-19
10815614020002CompressAR Compass Hand-Held Vascular Compression Assist Device3000130-0000-012016-09-24
10815614020804StatGuard Hemostatic Patch3010-00480-3010-002019-08-07
10815614020811StatGuard Hemostatic Dressing, Small3020-10480-3020-102018-09-27
10815614020828StatGuard Hemostatic Dressing, Regular3020-20480-3020-202019-02-28
10815614020033ComfortPress Hand-Held Vascular Compression Assist Device3100-13130-0100-132016-09-24
10815614020071RadAR Vascular Compression Device4150140-0150-002016-09-24
10815614020088RadAR Vascular Compression Device4160140-0160-002016-09-24
10815614020095RadAR EasyClik Vascular Compression Device4180140-0180-002016-09-24
10815614020118RadAR EasyClik Vascular Compression Device4185140-0185-002019-12-10
10815614020354ClampEase P-Series DiscP-700150-2031-702016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00818582013628Puracyn Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.FRO2026-10-16
00850744001432BloodSTOP iX Trauma SealLifescience Plus, Inc.QSY2026-10-16
00850744001456Trauma SealLifescience Plus, Inc.QSY2026-10-16
05059884011164Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011171Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011188Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011195Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011201Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011218Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011225Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
00841277111378Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111385Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111392Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111408Novera SeamHarps USA, Inc.FRO2026-10-14
10841277111382Novera SeamHarps USA, Inc.FRO2026-10-14
10841277111405Novera SeamHarps USA, Inc.FRO2026-10-14
00050428034712CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428034743CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428142349CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428341728CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
10885380214813DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214820DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214837DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214844DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214851DermaceaCardinal Health 200, LLCFRO2026-10-09
06977727072259Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072266Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072273Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072280Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072457SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08