Duns Number:316153865
Device Description: The QUART arterial filter (HBF 140) with SOFTLINE coating, sterile, is a screen filter wit 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.
Catalog Number
70103.2033
Brand Name
QUART
Version/Model Number
BO-HBF 140, SOFTLINE, Sterile
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 30, 2020
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K090518,K090518
Product Code
DTM
Product Code Name
Filter, blood, cardiopulmonary bypass, arterial line
Public Device Record Key
3f601ad2-b542-4c35-a427-9e88648fa02b
Public Version Date
April 30, 2020
Public Version Number
5
DI Record Publish Date
March 13, 2017
Package DI Number
04037691117911
Quantity per Package
8
Contains DI Package
04037691253862
Package Discontinue Date
April 30, 2020
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 286 |