AccessGUDID - DEVICE: GENTEC® (06970966662632)

GUDID

Device Identifier (DI) Information

Brand Name: GENTEC®
Version or Model: 882EV-70-R
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GENTEC(SHANGHAI)CORPORATION

Primary DI Number: 06970966662632
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 545287658 *Terms of Use

Device Description: 882EV series suction regulator is a continuous subglottic 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?
37782	Vacuum suction regulator/regulation set, thoracic	A noninvasive device/collection of noninvasive devices designed to connect to the terminal unit (wall outlet) of a vacuum pipeline system to control the degree of negative pressure during the evacuation of fluids (e.g., blood), secretions, or gases from the pleural cavity and/or mediastinum. The device allows suction at low levels (e.g., 0 - 40 mm Hg), includes a manometer and controls for monitoring/adjusting vacuum pressure, and may include collection containers, or tubing; it does not include patient contact devices (e.g., handpiece/tip, catheter).	Active	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: e74fa3a2-4bb8-4f9b-88d8-61372c400dcc
Public Version Date: May 13, 2020
Public Version Number: 2
DI Record Publish Date: September 27, 2018