AccessGUDID - DEVICE: ResQPOD ITD 10 (M5921202420000)

GUDID

Device Identifier (DI) Information

Brand Name: ResQPOD ITD 10
Version or Model: 12-0242-000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ADVANCED CIRCULATORY SYSTEMS INC

Primary DI Number: M5921202420000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 140320396 *Terms of Use

Device Description: The ResQPOD ITD 10 is indicated for the temporary increase in blood circulation.

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:	Yes
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?
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
JOW	Sleeve, Limb, Compressible
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a47e2f50-dd56-473d-be71-1fd2cafc16ca
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: November 11, 2016