BloodSTOP

Basic Information

• Brand Name: BloodSTOP
• Primary DI: 00850744001128
• Version / Model: BS-12
• Catalog Number: BS-12
• Company Name: Lifescience Plus, Inc.
• Labeler DUNS: 190600051
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2022-12-08
• Public Version: 3
• Public Version Date: 2024-01-15
• Public Version Status: Update
• Public Device Record Key: 6f45dfd3-e6ed-45e5-8add-8ad8b4b4ff26

Device Description

BloodSTOP Hemostat 4"x4" (10cmX10cm)

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
FRO	Dressing, Wound, Drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
58059	Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20850744001122	GS1	Case	20	In Commercial Distribution
Primary	00850744001128	GS1
Unit of Use	10850744001125	GS1

Device Sizes

Type	Value	Unit	Text
Area/Surface Area	16	Square inch

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius