AccessGUDID - DEVICE: Michigan Instruments, Inc. Life-Stat (00860682000121)

GUDID

Device Identifier (DI) Information

Brand Name: Michigan Instruments, Inc. Life-Stat
Version or Model: 1008
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 16000
Company Name: MICHIGAN INSTRUMENTS, LLC

Primary DI Number: 00860682000121
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081208064 *Terms of Use

Device Description: External Cardiac Compressor - Life-Stat

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Cardiac resuscitator, pneumatic	A pneumatically-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 is typically powered from medical gas cylinders or a medical gas pipeline system and may consist of a solid base with an attached band that straps across the patient's chest to produce the compressions, or have other configurations. The device is typically used as an adjunct to or substitute for manual external cardiac compression, to prevent fatigue and to provide better consistency in the applied force and rate of compression.

GMDN Preferred Term Name

GMDN Definition

Cardiac resuscitator, pneumatic

A pneumatically-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 is typically powered from medical gas cylinders or a medical gas pipeline system and may consist of a solid base with an attached band that straps across the patient's chest to produce the compressions, or have other configurations. The device is typically used as an adjunct to or substitute for manual external cardiac compression, to prevent fatigue and to provide better consistency in the applied force and rate of compression.

FDA Product Code

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Product Code	Product Code Name
DRM	Compressor, Cardiac, External

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K073079	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

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cea8dcaa-138f-4f69-9c92-b4389b600263
Public Version Date: July 18, 2018
Public Version Number: 4
DI Record Publish Date: September 12, 2014