AccessGUDID - DEVICE: QUART (04037691078977)

GUDID

Device Identifier (DI) Information

Brand Name: QUART
Version or Model: QUART Arterial Filter
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 70100.4263
Company Name: Maquet Cardiopulmonary AG

Primary DI Number: 04037691078977
Issuing Agency: GS1
Commercial Distribution End Date: April 30, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 316153865 *Terms of Use

Device Description: Quart Arterial Filter, no coating, HBF 140#Arterieller Filter Quart

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?
35071	Blood transfusion filter	A microporous device intended to be inserted, e.g., into a blood transfusion line, to remove debris from blood being infused into a patient. When used for arterial blood the device may also be used to trap gaseous (air) bubbles. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DTM	Filter, blood, cardiopulmonary bypass, arterial line

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K001787	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
Pore Size: 40 Micrometer
Device Size Text, specify: priming volume 180 Milliliter
Device Size Text, specify: connection size outlet 3/8 Inch
Device Size Text, specify: connection size inlet 3/8 Inch
Device Size Text, specify: maximum blood flow [l/min] 7 0
Area/Surface Area: 570 Square centimeter

Device Record Status

Public Device Record Key: 48d47f0a-5b35-46df-82ec-81737abfb31c
Public Version Date: June 02, 2023
Public Version Number: 6
DI Record Publish Date: October 24, 2015