Duns Number:240992693
Device Description: I.V. ADMINISTRATION EXTENSTION SET, COILED
Catalog Number
10-1309
Brand Name
MED-RX
Version/Model Number
10-1309
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
-
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
6aa48740-630c-4578-8747-9d769b1974b7
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 18, 2016
Package DI Number
50628725003714
Quantity per Package
100
Contains DI Package
00628725003719
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Corrugate Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 19 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |