Duns Number:053146767
Device Description: Reducing Connector - 22mm ID x 15mm ID. Fits components of adult ventilator circuits. Mol Reducing Connector - 22mm ID x 15mm ID. Fits components of adult ventilator circuits. Molded of silicone rubber. Reusable.
Catalog Number
PF 001
Brand Name
PF 001 Reducing Silicone Rubber Connector
Version/Model Number
PF 001
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
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
e341c89c-3f09-4944-97d5-2700f751c6e7
Public Version Date
September 20, 2021
Public Version Number
1
DI Record Publish Date
September 10, 2021
Package DI Number
M996PF0012
Quantity per Package
10
Contains DI Package
M996PF0010
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Ziplock Bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 229 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 71 |