AccessGUDID - DEVICE: ROSC-U System (00860000876209)

GUDID

Device Identifier (DI) Information

Brand Name: ROSC-U System
Version or Model: A03-01-000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A03-01-000
Company Name: RESUSCITATION INTERNATIONAL, LLC

Primary DI Number: 00860000876209
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053006828 *Terms of Use

Device Description: Mechanical CPR system, including Battery Control Unit, Compressor, Torso Restraints (10 pk), Torso Restraints XL (5 pk), Battery Charger

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:	No
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?
61908	Cardiac resuscitator, battery-powered	A battery-powered external device designed 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)]. It may be available in a variety of forms but includes a mechanical chest compressor (e.g., plunger-type), a battery-powered control unit, and patient straps/supports. The device is typically used as an adjunct to or substitute for manual external cardiac compression in cases where manual compression is not ideal, or to prevent fatigue and improve consistency (i.e., of force, rate).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRM	Compressor, Cardiac, External

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: b1212136-6466-469e-99f1-37487c856806
Public Version Date: December 23, 2019
Public Version Number: 1
DI Record Publish Date: December 13, 2019