AccessGUDID - DEVICE: Ohio Medical Vacuum Regulator (08688250002023)

GUDID

Device Identifier (DI) Information

Brand Name: Ohio Medical Vacuum Regulator
Version or Model: PC2HD
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: OHIO MEDICAL, LLC

Primary DI Number: 08688250002023
Issuing Agency: GS1
Commercial Distribution End Date: April 30, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 005192885 *Terms of Use

Device Description: Vacuum Regulator, Push to Set, Continuous 2Mode, 760mmHg Digital

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:	No
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?
44809	Vacuum suction regulator/regulation set, general-purpose	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, mucus, or solids during a range of clinical applications (e.g., not dedicated to thoracic suction). It allows continuous and/or intermittent suction at variable levels, incorporates a manometer and controls for monitoring/adjusting the level of suction, and may include collection containers, tubing or a stand/mount; 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: a9dd86a0-b552-4294-a93e-67b7fc7bc7b6
Public Version Date: April 30, 2020
Public Version Number: 5
DI Record Publish Date: September 24, 2016