Duns Number:094651270
Device Description: DELTRAN II - ABC SYSTEM, Disposable Pressure Transducer System, 3cc/hr Flow Rate with the DELTRAN II - ABC SYSTEM, Disposable Pressure Transducer System, 3cc/hr Flow Rate with the Arterial Blood Collection System
Catalog Number
902-605
Brand Name
DELTRAN
Version/Model Number
Custom
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
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
-
Product Code
CBT
Product Code Name
Arterial Blood Sampling Kit
Public Device Record Key
29510a53-2542-4ccb-ac46-ae8e4cdc6fd6
Public Version Date
December 18, 2019
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
H6719026051
Quantity per Package
10
Contains DI Package
H6719026050
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 274 |