AccessGUDID - DEVICE: simex (04052262076725)

GUDID

Device Identifier (DI) Information

Brand Name: simex
Version or Model: suction tube 50 cm
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 112201
Company Name: SIMEX Medizintechnik GmbH

Primary DI Number: 04052262076725
Issuing Agency: GS1
Commercial Distribution End Date: November 16, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 344498415 *Terms of Use

Device Description: Suction tube, 50cm, Luer, sterile

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:	Yes
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?
34923	Suction system catheter, general-purpose	A sterile flexible tube used in the removal of fluids from the body via a natural body orifice, surgical incision, or wound. It is typically designed to be attached to a collection canister or bottle where a vacuum is created by a suction system via an intermediate tubing. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAZ	Tubing, Noninvasive

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: Yes
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: 152c5f34-b350-4d7d-8610-ee4ee93500fb
Public Version Date: April 12, 2018
Public Version Number: 3
DI Record Publish Date: September 19, 2016