AccessGUDID - DEVICE: QUADROX-i (04037691965307)

GUDID

Device Identifier (DI) Information

Brand Name: QUADROX-i
Version or Model: Small Adult, reservoir
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 70106.4527
Company Name: Maquet Cardiopulmonary AG

Primary DI Number: 04037691965307
Issuing Agency: GS1
Commercial Distribution End Date: February 01, 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?
31710	Cardiotomy reservoir	A device intended to be integrated within an extracorporeal circuit to collect, store, and filter blood typically during a cardiopulmonary bypass procedure; it does not include additional functional components such as an oxygenator. It is typically a hardshell or soft, bag-like container with connectors designed to trap micro-particles and air bubbles for a period of time (e.g., 6 hours) and hold a reserve supply of blood; some types may also defoam. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DTP	Defoamer, cardiopulmonary bypass
JOD	FILTER, BLOOD, CARDIOTOMY SUCTION LINE, CARDIOPULMONARY BYPASS
DTN	RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K132166	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
No Device Sizes

Device Record Status

Public Device Record Key: 910708b5-0249-4263-86af-5b7c1449e921
Public Version Date: February 03, 2020
Public Version Number: 6
DI Record Publish Date: October 24, 2015