Duns Number:092673953
Device Description: 72" 28V Pediatric HW Circuit, Par-Wye, GSE, BV Filter, Water, 1L/Lf Bag
Catalog Number
-
Brand Name
Filter
Version/Model Number
A4334
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
BZE
Product Code Name
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Public Device Record Key
229b9ec9-8a2c-432d-8a48-8f72d2f37893
Public Version Date
October 24, 2022
Public Version Number
5
DI Record Publish Date
February 20, 2017
Package DI Number
10709078001113
Quantity per Package
18
Contains DI Package
00709078001116
Package Discontinue Date
-
Package Status
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 | 746 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 320 |