HemoBand HB-1M

GUDID 00865165000223

HemoBand Sterile HB-1M (Standard Length - 14")

INNOVATIONS FOR ACCESS INC

Haemodialysis arm clamp

• Primary Device ID: 00865165000223
• NIH Device Record Key: afc82cd5-11bb-4cd0-96ac-5e6c7a323859
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HemoBand
• Version Model Number: HB-1M
• Catalog Number: HB-1M
• Company DUNS: 051632466
• Company Name: INNOVATIONS FOR ACCESS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-297-8485
• Email: orders@hemoband.net
• Phone: 1-800-297-8485
• Email: orders@hemoband.net
• Phone: 1-800-297-8485
• Email: orders@hemoband.net
• Phone: 1-800-297-8485
• Email: orders@hemoband.net
• Phone: 1-800-297-8485
• Email: orders@hemoband.net
• Phone: 1-800-297-8485
• Email: orders@hemoband.net
• Phone: 1-800-297-8485
• Email: orders@hemoband.net
• Phone: 1-800-297-8485
• Email: orders@hemoband.net
• Phone: 1-800-297-8485
• Email: orders@hemoband.net
• Phone: 1-800-297-8485
• Email: orders@hemoband.net
• Phone: 1-800-297-8485
• Email: orders@hemoband.net
• Phone: 1-800-297-8485
• Email: orders@hemoband.net
• Phone: 1-800-297-8485
• Email: orders@hemoband.net
• Phone: 1-800-297-8485
• Email: orders@hemoband.net
• Phone: 1-800-297-8485
• Email: orders@hemoband.net
• Phone: 1-800-297-8485
• Email: orders@hemoband.net
• Phone: 1-800-297-8485
• Email: orders@hemoband.net
• Phone: 1-800-297-8485
• Email: orders@hemoband.net
• Phone: 1-800-297-8485
• Email: orders@hemoband.net
• Phone: 1-800-297-8485
• Email: orders@hemoband.net
• Phone: 1-800-297-8485
• Email: orders@hemoband.net
• Phone: 1-800-297-8485
• Email: orders@hemoband.net
• Phone: 1-800-297-8485
• Email: orders@hemoband.net
• Phone: 1-800-297-8485
• Email: orders@hemoband.net
• Phone: 1-800-297-8485
• Email: orders@hemoband.net
• Phone: 1-800-297-8485
• Email: orders@hemoband.net
• Phone: 1-800-297-8485
• Email: orders@hemoband.net
• Phone: 1-800-297-8485
• Email: orders@hemoband.net
• Phone: 1-800-297-8485
• Email: orders@hemoband.net
• Phone: 1-800-297-8485
• Email: orders@hemoband.net
• Phone: 1-800-297-8485
• Email: orders@hemoband.net
• Phone: 1-800-297-8485
• Email: orders@hemoband.net
• Phone: 1-800-297-8485
• Email: orders@hemoband.net
• Phone: 1-800-297-8485
• Email: orders@hemoband.net
• Phone: 1-800-297-8485
• Email: orders@hemoband.net
• Phone: 1-800-297-8485
• Email: orders@hemoband.net
• Phone: 1-800-297-8485
• Email: orders@hemoband.net

Device Dimensions

• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00865165000223 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K920614

FDA Product Code

• KOC: Accessories, Blood Circuit, Hemodialysis

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-11
• Device Publish Date: 2020-09-03

On-Brand Devices [HemoBand]

• 00865165000223: HemoBand Sterile HB-1M (Standard Length - 14")
• 00865165000216: HemoBand Non-Sterile HB-NS (Standard Length - 14")
• 00865165000209: HemoBand Non-Sterile XL HB-NSXL (Extra Long Length - 17")