Duns Number:094651270
Device Description: "INFANT DRAW" Disposable Pressure Transducer, Neonatal, 30cc/hr Flow Rate, Arterial Blood "INFANT DRAW" Disposable Pressure Transducer, Neonatal, 30cc/hr Flow Rate, Arterial Blood Collection System, 6cc Reservoir, For Use with Syringe Pumps, 24" Line
Catalog Number
ABC-328NP
Brand Name
DELTRAN
Version/Model Number
II - PLUS
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
f111a0f1-c602-49bc-a925-594c094d3400
Public Version Date
December 18, 2019
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
H671ABC328NP1
Quantity per Package
10
Contains DI Package
H671ABC328NP0
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 |