Duns Number:032705659
Catalog Number
-
Brand Name
Neo-Tee T-Piece Resuscitator Circuit
Version/Model Number
10-50900
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
K093913,K093913
Product Code
BTL
Product Code Name
Ventilator, Emergency, Powered (Resuscitator)
Public Device Record Key
d25cae00-71fa-4050-93c2-01056788f23e
Public Version Date
May 08, 2020
Public Version Number
4
DI Record Publish Date
December 06, 2017
Package DI Number
30641043509009
Quantity per Package
10
Contains DI Package
10641043509005
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 | 120 |
2 | A medical device with a moderate to high risk that requires special controls. | 728 |