ReadyRip Belt - Single use, large respiratory belt. - Cleveland Medical Devices Inc.

Duns Number:557510625

Device Description: Single use, large respiratory belt.

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More Product Details

Catalog Number

502-0204-3

Brand Name

ReadyRip Belt

Version/Model Number

Large - Single

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

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

K042039,K042039,K042039

Product Code Details

Product Code

GWQ

Product Code Name

Full-Montage Standard Electroencephalograph

Device Record Status

Public Device Record Key

fbfd442f-0b83-44c1-bd0d-71df0414b60f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

B14360201031

Quantity per Package

25

Contains DI Package

B143502020430

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"CLEVELAND MEDICAL DEVICES INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 20