BleedBloc Hemostatic Gauze

Basic Information

• Brand Name: BleedBloc Hemostatic Gauze
• Primary DI: 07290016339901
• Version / Model: Double Pack 2" X 2" (5cm X 5cm) US
• Catalog Number: 105055902
• Company Name: CORE SCIENTIFIC CREATIONS LTD
• Labeler DUNS: 600041570
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-01
• Public Version: 1
• Public Version Date: 2023-09-11
• Public Version Status: New
• Public Device Record Key: bccc5f5e-3d3c-470b-8735-a7463e7536ae

Device Description

BleedBloc is a soluble dressing, based on cellulosic structure. In contact with liquids it forms absorbent gel which adheres to the wound surface to control bleeding. BleedBloc is intended to be used as a topical dressing for minor skin surface bleeding wounds such as minor cuts and minor abrasions.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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: Yes
• 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
38771	Plant polysaccharide haemostatic agent, bioabsorbable	A bioabsorbable device derived from plant polysaccharides (e.g., starch, agar derivative, cellulose-derived) intended for topical application to a traumatic wound (e.g., abrasion, laceration, cut), ulcer, and/or surgical wound to facilitate local haemostasis; it is not dedicated to bone haemostasis. It is available in various forms (e.g., liquid, spray, foam, particles, foam pad/sponge, bandage strip, gauze pad) that can be applied directly to the wound where it remains to be absorbed by the body; it does not contain an antimicrobial agent. It may be used in combination with supplemental agents (e.g., vitamin K-dependent coagulation factors). This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	17290016339908	GS1	Foil	2	In Commercial Distribution
Primary	07290016339901	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K160679	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 41 – 95 Degrees Fahrenheit