AccessGUDID - DEVICE: RetroGuard Arterial Safety Valve (10634624472003)

GUDID

Device Identifier (DI) Information

Brand Name: RetroGuard Arterial Safety Valve
Version or Model: 4007200
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4007200
Company Name: QUEST MEDICAL INC

Primary DI Number: 10634624472003
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 041810693 *Terms of Use

Device Description: No description.

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?
17581	Cardiopulmonary bypass system valve, unidirectional flow/pressure control	A sterile, mechanical regulator used in a cardiopulmonary bypass system, particularly systems employing centrifugal pumps during open-heart surgery. It typically provides unidirectional flow to prevent inadvertent backflow of blood and air into the heart, and/or controls the pressure within the system (e.g., maintains gentle suction to prevent line collapse during left ventricular venting, or controls the vacuum from suctioning of the heart or the surgical field). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MJJ	Cpb Check Valve, Retrograde Flow, In-Line

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: Yes

Sterilization Method [?]
Ethylene Oxide

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: 495b6a89-8545-41ec-9059-1df1a72cf553
Public Version Date: November 13, 2019
Public Version Number: 3
DI Record Publish Date: June 06, 2016