ROSC-U Head Stabilizer - Head Stabilizer used to limit head movement - RESUSCITATION INTERNATIONAL, LLC

Duns Number:053006828

Device Description: Head Stabilizer used to limit head movement during resuscitation

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More Product Details

Catalog Number

A02-55-135

Brand Name

ROSC-U Head Stabilizer

Version/Model Number

A02-55-135

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

-

Product Code Details

Product Code

DRM

Product Code Name

Compressor, Cardiac, External

Device Record Status

Public Device Record Key

d45df803-4b12-4cff-ae9c-09e183b66cab

Public Version Date

December 23, 2019

Public Version Number

1

DI Record Publish Date

December 13, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RESUSCITATION INTERNATIONAL, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 9