AccessGUDID - DEVICE: CirQPOD System (00847946028350)

GUDID

Device Identifier (DI) Information

Brand Name: CirQPOD System
Version or Model: 12-2415-000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Zoll Medical Corporation

Primary DI Number: 00847946028350
Issuing Agency: GS1
Commercial Distribution End Date: February 17, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 055363428 *Terms of Use

Device Description: CIRQPOD SYSTEM

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58941	Cardiopulmonary resuscitation impedance valve, inspiratory	A non-sterile valve intended to increase blood flow to the heart and brain of a patient during cardiopulmonary resuscitation (CPR) by selectively impeding inspiratory gases during the release phase of CPR resulting in increased negative pressure in the thorax, greater venous return to the heart, and increased blood flow during the next compression. It is designed to connect between a ventilation source (e.g., pulmonary resuscitator) and an airway adjunct (e.g., face mask, breathing tube) and is typically comprised of a valve diaphragm (e.g., silicone) with a ventilation port and supplemental features [e.g., safety mechanism, visual metronome (battery-powered)]. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BWF	SPIROMETER, THERAPEUTIC (INCENTIVE)

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
Handling Environment Temperature: exactly 0 Degrees Celsius
Storage Environment Atmospheric Pressure: more than 0 KiloPascal
Storage Environment Humidity: exactly 0 Percent (%) Relative Humidity
Storage Environment Temperature: exactly 0 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 69ae5329-89ab-4e75-8fd2-7851c62b99f9
Public Version Date: April 27, 2022
Public Version Number: 2
DI Record Publish Date: July 01, 2020