Duns Number:071595540
Device Description: PROFORMA HF 4.5 Cannula, Straight Taper Tip
Catalog Number
050906
Brand Name
PROFORMA
Version/Model Number
050906
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 04, 2017
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"
-
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
K950700,K950700,K950700
Product Code
DSA
Product Code Name
CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
Public Device Record Key
b67177cd-b360-470e-a993-c0c41eea46f2
Public Version Date
November 19, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
10653405051411
Quantity per Package
5
Contains DI Package
20653405051418
Package Discontinue Date
April 04, 2017
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 | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |