AccessGUDID - DEVICE: QUART (04037691253862)

GUDID

Device Identifier (DI) Information

Brand Name: QUART
Version or Model: BO-HBF 140, SOFTLINE, Sterile
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 70103.2033
Company Name: Maquet Cardiopulmonary AG

Primary DI Number: 04037691253862
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: The QUART arterial filter (HBF 140) with SOFTLINE coating, sterile, is a screen filter with integrated bypass and pre-postdeairing mechanic. It is used for removing gaseous embolisms and aggregates from blood components of the arterial bloodline during extracorporeal circulation. Therefore utilization of the arterial filter reduces the patient’s risk of injury from a micro embolism caused by gases or solids.

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 [?]
K090518	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
Area/Surface Area: 570 Square centimeter
Device Size Text, specify: maximum blood flow [l/min] 7 0
Device Size Text, specify: connection size inlet 3/8 Inch
Device Size Text, specify: connection size outlet 3/8 Inch
Device Size Text, specify: priming volume 180 Milliliter
Pore Size: 40 Micrometer

Device Record Status

Public Device Record Key: 3f601ad2-b542-4c35-a427-9e88648fa02b
Public Version Date: June 02, 2023
Public Version Number: 6
DI Record Publish Date: March 13, 2017