Duns Number:001660786
Device Description: BEQ-HMOD 30000-USA Pediatric Quadrox iD,Better Bladder 1/4,BC 60 plus,Blood Microfilter Sy BEQ-HMOD 30000-USA Pediatric Quadrox iD,Better Bladder 1/4,BC 60 plus,Blood Microfilter System SQ 40 S,Pediatric Temp Probe
Catalog Number
709000069R02
Brand Name
Custom ECC Pk-Neonatal 1/4"
Version/Model Number
BEQ-TOP 50900
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 12, 2019
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"
Yes
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
-
Product Code
DWE
Product Code Name
Tubing, Pump, Cardiopulmonary Bypass
Public Device Record Key
0b0ff461-fb3a-4eff-af2e-6d984a72e4c5
Public Version Date
June 12, 2019
Public Version Number
4
DI Record Publish Date
September 20, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 663 |