HemoBand

Basic Information

• Brand Name: HemoBand
• Primary DI: 00865165000209
• Version / Model: HB-NSXL
• Catalog Number: HB-NSXL
• Company Name: INNOVATIONS FOR ACCESS INC
• Labeler DUNS: 051632466
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-12
• Public Version: 3
• Public Version Date: 2020-10-22
• Public Version Status: Update
• Public Device Record Key: 93ae5d6f-865a-48cd-8801-e20b7cf0ca2a

Device Description

HemoBand Non-Sterile XL HB-NSXL (Extra Long Length - 17")

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: 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Liquid Chemical

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KOC	Accessories, Blood Circuit, Hemodialysis	Gastroenterology, Urology	876.5820	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65119	Vascular puncture haemostasis arm clamp/band, single-use	A semi-flexible, adjustable, clamp or band/strap device designed for application over an arterial/venous/fistula needle-puncture site on a patient’s arm to provide uniform pressure and achieve haemostasis. Commonly used on haemodialysis patients, some types are referred to as fistula clamps. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00865165000209	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K081740	000

Device Sizes

Type	Value	Unit	Text
Length	17	Inch