StatGuard Hemostatic Dressing, Regular

Basic Information

• Brand Name: StatGuard Hemostatic Dressing, Regular
• Primary DI: 10815614020828
• Version / Model: 3020-20
• Catalog Number: 480-3020-20
• Company Name: SEMLER TECHNOLOGIES, INC.
• Labeler DUNS: 042075700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-28
• Public Version: 4
• Public Version Date: 2023-08-29
• Public Version Status: Update
• Public Device Record Key: d24083d9-aff6-4ed5-8680-c07deb7ef18b

Device Description

The StatGuard Hemostatic Dressing is composed of a non-woven gauze made of chitosan which is applied to an arterial or venous puncture or incision to promote post-procedure hemostasis and control of moderate to severe wound bleeding, exudates absorption, and coagulation. Model 3020-10 provides a 2 cm x 3.5 cm gauze, in an 8 cm x 10 cm adhesive dressing

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
46922	Chitosan haemostatic agent, professional	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10815614020828	GS1
Package	20815614020825	GS1	Box	20	In Commercial Distribution
Package	30815614020822	GS1	Carton	10	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K172155	000