QUIKCLOT

Basic Information

• Brand Name: QUIKCLOT
• Primary DI: 10841495150231
• Version / Model: IPN928785
• Catalog Number: 183
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-08
• Public Version: 4
• Public Version Date: 2024-02-27
• Public Version Status: Update
• Public Device Record Key: 46e7993f-8216-4d85-aee6-ede39b426f8f

Device Description

QuikClot Interventional w/ Tegaderm

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: No
• MRI Safety: MR Safe
• 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
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	30841495150235	GS1	Case	8	In Commercial Distribution
Package	20841495150238	GS1	Box	10	In Commercial Distribution
Primary	10841495150231	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 77 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Storage Environment Temperature