Duns Number:604208868
Device Description: #1392 IV Start Kit L/FContents: (1) Tegaderm Dressing, (1) Tourniquet L/F, (1) Sponge 4x4 #1392 IV Start Kit L/FContents: (1) Tegaderm Dressing, (1) Tourniquet L/F, (1) Sponge 4x4 2/Pk, (2) Alcohol Prep Pad, (1) Towel 2-Ply Poly
Catalog Number
392
Brand Name
Motion Medical Distributing
Version/Model Number
1392
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
39946fd8-e917-42de-b39c-2e66584c4e1a
Public Version Date
March 31, 2020
Public Version Number
1
DI Record Publish Date
March 23, 2020
Package DI Number
25060498452049
Quantity per Package
50
Contains DI Package
15060498452042
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 |