AccessGUDID - DEVICE: LifeBand® Load-distributing Band (10849111001691)

GUDID

Device Identifier (DI) Information

Brand Name: LifeBand® Load-distributing Band
Version or Model: 100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8700-0706-01
Company Name: Zoll Circulation, Inc.

Primary DI Number: 10849111001691
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 799455241 *Terms of Use

Device Description: Single-use chest compression band. (3 per package)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRM	Compressor, Cardiac, External

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K112998	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: aa2c916b-7f82-40c4-b71c-8b2e4bdb0a42
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 24, 2015