LifeBand® Load-distributing Band

Basic Information

• Brand Name: LifeBand® Load-distributing Band
• Primary DI: 00849111065016
• Version / Model: 100
• Catalog Number: 8700-0701-03
• Company Name: Zoll Circulation, Inc.
• Labeler DUNS: 799455241
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-07-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 2d79633f-f216-4821-997c-642b084ed045

Device Description

Single-use chest compression band. (1 per package)

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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DRM	Compressor, Cardiac, External	Cardiovascular	870.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44892	Cardiac resuscitator band	A wide belt intended to be applied across the chest as part of an automated cardiac resuscitator, for the application of rhythmic compression to the chest in the region of the heart to provide blood flow during treatment of cardiac arrest [cardiopulmonary resuscitation (CPR)]. The device is typically used on adult patients only and may be adjusted to accommodate a range of chest circumferences. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00849111065016	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K112998	000