AccessGUDID - DEVICE: Heimlich valve (08034139291130)

GUDID

Device Identifier (DI) Information

Brand Name: Heimlich valve
Version or Model: 10530
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10530
Company Name: REDAX SPA

Primary DI Number: 08034139291130
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 338664915 *Terms of Use

Device Description: The Heimlich non-return valve is a one-way drainage device which prevents the air reflux towards the patient's chest.

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?
62752	Pleural drainage valve	A sterile, noninvasive device in the form of a small polymer housing intended to be connected to a pleural catheter to prevent backflow of gas into the pleural cavity during drainage of fluid and gas from the pleural cavity. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDQ	Bottle, Collection, Vacuum

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dcd45105-c159-4137-8f56-dda2e5bd6ff1
Public Version Date: April 06, 2020
Public Version Number: 1
DI Record Publish Date: March 27, 2020