AccessGUDID - DEVICE: NA (04037691235042)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: Ven.Cath.,reinf.,Bullet tip,90° bent
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 70100.4590
Company Name: Maquet Cardiopulmonary AG

Primary DI Number: 04037691235042
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: Venous Catheter, wire reinforced, Bullet tip, 90° bent

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?
34905	Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, venous	A semi-rigid or rigid tube intended to be surgically inserted into the right atrium or large vein to serve as a channel for the extracorporeal transport of deoxygenated blood from a patient during cardiopulmonary bypass and/or extracorporeal membrane oxygenation. It is typically inserted using a compatible trocar blade which may be included. 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 [?]
K020784	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: connection size 1/4 inch
Length: 33 Centimeter
Angle: 90 degree
Catheter Gauge: 20 French
Device Size Text, specify: Tip length 5.0 Centimeter

Device Record Status

Public Device Record Key: 51757b21-8eff-4c2c-8230-7847fdd9eb61
Public Version Date: August 05, 2022
Public Version Number: 6
DI Record Publish Date: June 03, 2016