Duns Number:632707092
Device Description: Following Device Identifier number are included in this KIT:17325710002596,17325710004576
Catalog Number
-
Brand Name
Starter Kit Ventilation,neonatal
Version/Model Number
6880511
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 11, 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"
-
For Single-Use
-
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
CAI
Product Code Name
Circuit, Breathing (W Connector, Adaptor, Y Piece)
Public Device Record Key
0fd321a4-0450-4938-b7ab-7941e6ddbe22
Public Version Date
October 24, 2022
Public Version Number
4
DI Record Publish Date
November 27, 2015
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 62 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 131 |