Duns Number:604208868
Device Description: #1211 IV Start KitContents: (1) IV Guard Dressing, (1) Transpore Tape 1527, (1) Tourniquet #1211 IV Start KitContents: (1) IV Guard Dressing, (1) Transpore Tape 1527, (1) Tourniquet Latex-Free, (1) Sponge 2x2 2/Pk, (1) Alcohol Prep Pad, (1) PVP Prep Pad, (1) Adhesive Bandage, (1) Saline Flush 10mL, (1) Extension Set 8"
Catalog Number
1211
Brand Name
Motion Medical Distributing
Version/Model Number
1211
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)
-
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
0ab4444f-4bf0-4b30-8375-76dcb4cc1ba5
Public Version Date
December 11, 2019
Public Version Number
2
DI Record Publish Date
September 18, 2019
Package DI Number
25060498451936
Quantity per Package
50
Contains DI Package
15060498451939
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 |