AccessGUDID - DEVICE: NA (04037691144184)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: Rigid sucker with mini-tip
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 70100.4972
Company Name: Maquet Cardiopulmonary AG

Primary DI Number: 04037691144184
Issuing Agency: GS1
Commercial Distribution End Date: January 31, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 316153865 *Terms of Use

Device Description: No description.

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:	Yes
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?
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
DWF	CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K020983	000

Device Exempt from Premarket Submission: No 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
Device Size Text, specify: Steel tube inner diameter 3.4 Millimeter
Device Size Text, specify: Tip outer diamteter 9 French
Device Size Text, specify: Connector 1/4 Inch
Length: 27 Centimeter

Device Record Status

Public Device Record Key: c25ae84a-287d-4937-86df-02f922d77e34
Public Version Date: January 31, 2020
Public Version Number: 5
DI Record Publish Date: October 24, 2015