Duns Number:053146767
Device Description: Straight Connector - 10mm ID x 10mm ID. Fits components of neonatal ventilator circuits. Straight Connector - 10mm ID x 10mm ID. Fits components of neonatal ventilator circuits. Molded of silicone rubber. Reusable.
Catalog Number
PF 1010
Brand Name
PF 1010 Straight Silicone Rubber Connector
Version/Model Number
PF 1010
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
b4159384-796a-405c-9445-85ab3900d716
Public Version Date
September 20, 2021
Public Version Number
1
DI Record Publish Date
September 10, 2021
Package DI Number
M996PF10102
Quantity per Package
10
Contains DI Package
M996PF10100
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 |