Duns Number:604208868
Device Description: #1212S IV Start KitContents: (1) IV Dressing, (1) Tourniquet Latex, (1) Sponge 4x4, (1) Al #1212S IV Start KitContents: (1) IV Dressing, (1) Tourniquet Latex, (1) Sponge 4x4, (1) Alcohol Prep Pad, (1) Antimicrobial Prep Pad, (1) Biohazard Bag, (1) Sharps Shuttle
Catalog Number
1212S
Brand Name
Motion Medical Distributing
Version/Model Number
1212S
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LRS
Product Code Name
I.V. Start Kit
Public Device Record Key
d83d1efd-64a1-4952-af3b-8102c2af4e92
Public Version Date
December 11, 2019
Public Version Number
3
DI Record Publish Date
October 18, 2016
Package DI Number
25060498450595
Quantity per Package
50
Contains DI Package
15060498450598
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 190 |