LifeBand® Load-distributing Band - Single-use chest compression band. (3 per - Zoll Circulation, Inc.

Duns Number:799455241

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

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More Product Details

Catalog Number

8700-0706-20

Brand Name

LifeBand® Load-distributing Band

Version/Model Number

100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K112998,K112998

Product Code Details

Product Code

DRM

Product Code Name

Compressor, Cardiac, External

Device Record Status

Public Device Record Key

0b759e20-5cc3-4297-95f1-b93ea6c24556

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ZOLL CIRCULATION, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 331
3 A medical device with high risk that requires premarket approval 1