Duns Number:368457563
Device Description: T-Piece Neonatal Patient Circuit Kit, Disposable
Catalog Number
-
Brand Name
N/A
Version/Model Number
M1091365VS
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"
-
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
K093913,K093913
Product Code
BTL
Product Code Name
Ventilator, Emergency, Powered (Resuscitator)
Public Device Record Key
95f32a18-81d9-47e2-85a2-29785fb33902
Public Version Date
October 24, 2022
Public Version Number
3
DI Record Publish Date
April 15, 2019
Package DI Number
20190752135694
Quantity per Package
10
Contains DI Package
10190752135697
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 | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 600 |