FDA UDI
In Commercial Distribution
🇺🇸 United States
StatGuard Hemostatic Patch
DI: 10815614020804
·
Model: 3010-00
·
SEMLER TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- StatGuard Hemostatic Patch
- Primary DI
- 10815614020804
- Version / Model
- 3010-00
- Catalog Number
- 480-3010-00
- Company Name
- SEMLER TECHNOLOGIES, INC.
- Labeler DUNS
- 042075700
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-07
- Public Version
- 4
- Public Version Date
- 2023-08-29
- Public Version Status
- Update
- Public Device Record Key
- b97fc98b-4d65-402a-92c9-6e93e73c5bbb
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.
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 |
|---|---|---|---|---|---|---|
| Package | 30815614020808 | GS1 | Carton | 10 | In Commercial Distribution | |
| Package | 20815614020801 | GS1 | Box | 20 | In Commercial Distribution | |
| Primary | 10815614020804 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172155 | 000 |