Duns Number:015222912
Device Description: Neonatal / Infant patient circuit, disposable, single patient use, 10 mm ID, 8 foot long e Neonatal / Infant patient circuit, disposable, single patient use, 10 mm ID, 8 foot long each.
Catalog Number
58201
Brand Name
pNeuton
Version/Model Number
58201
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
K121379,K121379
Product Code
CBK
Product Code Name
Ventilator, Continuous, Facility Use
Public Device Record Key
93c292cb-6b1a-48eb-a16c-bf32e1734f2e
Public Version Date
October 24, 2022
Public Version Number
3
DI Record Publish Date
June 17, 2019
Package DI Number
00853678006702
Quantity per Package
10
Contains DI Package
00853678006696
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 34 |