AccessGUDID - DEVICE: AutoPulse®Resuscitation System (00849111001489)

GUDID

Device Identifier (DI) Information

Brand Name: AutoPulse®Resuscitation System
Version or Model: 100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Zoll Circulation, Inc.

Primary DI Number: 00849111001489
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 799455241 *Terms of Use

Device Description: The AutoPulse Resuscitation System Model 100 is an automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR.

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?
44780	Cardiac resuscitator, line-powered	A mains electricity (AC-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)]. The device 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRM	Compressor, Cardiac, External

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K112998	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

[?]

Storage and Handling
Handling Environment Temperature: between 32 and 104 Degrees Fahrenheit
Handling Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -4 and 149 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0ce75e2a-bbd8-4ff6-802e-29d0af6c6d50
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 24, 2015