Duns Number:008999906
Device Description: Use of the SmartNeedle device is indicated when blood flow must be detected for percutaneo Use of the SmartNeedle device is indicated when blood flow must be detected for percutaneous vessel cannulation. The vessel must be of a caliber which would normally be punctured with a needle and/or catheter of this size or larger.
Catalog Number
-
Brand Name
SmartNeedle® vascular access system
Version/Model Number
78120
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 06, 2020
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"
-
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
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
6031e4ed-4319-40a0-b9e1-b6262a05ed7a
Public Version Date
March 24, 2020
Public Version Number
5
DI Record Publish Date
September 06, 2016
Package DI Number
M206781201
Quantity per Package
10
Contains DI Package
M206781200
Package Discontinue Date
March 06, 2020
Package Status
Not 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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 238 |
| U | Unclassified | 12 |