Duns Number:022721133
Device Description: Endotracheal Tube, Preformed, Oral, Low Profile Cuffed (PFOL), Parker, 3.5mmParker Origina Endotracheal Tube, Preformed, Oral, Low Profile Cuffed (PFOL), Parker, 3.5mmParker Original DID: 1074906505130353.
Catalog Number
H-PFOL-35
Brand Name
Parker
Version/Model Number
H-PFOL-35
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
K984528,K984528,K984528
Product Code
BTR
Product Code Name
Tube, Tracheal (W/Wo Connector)
Public Device Record Key
9b50f0fc-5aab-4375-a0ba-27db629b1e74
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
August 03, 2018
Package DI Number
20607411959404
Quantity per Package
100
Contains DI Package
00607411959400
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 | 865 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1134 |