AccessGUDID - DEVICE: GENTEC® (06970966661529)

GUDID

Device Identifier (DI) Information

Brand Name: GENTEC®
Version or Model: 882VR-160-DH-T
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GENTEC(SHANGHAI)CORPORATION

Primary DI Number: 06970966661529
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 545287658 *Terms of Use

Device Description: 882VR series suction regulator is a suction regulator .It can be used for medical suction and enables the clinician to control the level of negative pressure for the operation of pharyngeal aspiration, tracheal suctioning etc.

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
37783	Tracheal suction vacuum regulator	A device designed to connect to the vacuum terminal unit (wall outlet) of a vacuum pipeline system to control the degree of negative pressure (vacuum) provided by the system and applied in the evacuation of fluids, mucus or solids from the trachea. The device is connected either directly or via dedicated vacuum tubing to the wall outlet and helps provide continuous or intermittent suction at variable levels. It is typically constructed of metal and plastic and includes a manometer for monitoring suction/vacuum pressure. It may include a disposable antibacterial filter, a collection bottle and a mechanical anti-overflow mechanism to help protect the device and the vacuum pipeline system.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KDP	Regulator, 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: 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: 6042b012-185a-4261-8b1e-8ffd4e2a55ef
Public Version Date: May 13, 2020
Public Version Number: 3
DI Record Publish Date: June 01, 2017