AccessGUDID - DEVICE: ME+600 _ DS _ G1/2 G (08592346755031)

GUDID

Device Identifier (DI) Information

Brand Name: ME+600 _ DS _ G1/2 G
Version or Model: 0735102US
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GCE, s.r.o.

Primary DI Number: 08592346755031
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 819753190 *Terms of Use

Device Description: MediEvac+ is variable control medical suction equipment powered from a vacuum source used for vacuum regulation. MediEvac+ is intended for suction of body liquids from any part of a patient's body during surgical operations, resuscitation, chest and gastritic drainage, etc. The product is not intended to be powered from: • a venturi vacuum source • a pressure gas source. The product is not intended for: • field use • direct use during thoracic drainage

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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):	No
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: 16cd2ac9-2ba5-447a-86be-0b423cf99498
Public Version Date: February 25, 2021
Public Version Number: 1
DI Record Publish Date: February 17, 2021