Duns Number:604208868
Device Description: #1683 Chest Decompression KitContents: (4) PVP Swabstick Single, (3) Sponge 4x4 2/Pk, (2) #1683 Chest Decompression KitContents: (4) PVP Swabstick Single, (3) Sponge 4x4 2/Pk, (2) Gloves L/F Pair, (2) Syringe 20cc, (4) Catheter 14Gx2", (2) Catheter 16Gx2"
Catalog Number
1683
Brand Name
Motion Medical Distributing
Version/Model Number
1683
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
OWL
Product Code Name
Peripheral Catheter Insertion Kit
Public Device Record Key
be2fbfbb-7a36-4e49-8ff3-19a774770a25
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 15, 2016
Package DI Number
25060498450205
Quantity per Package
10
Contains DI Package
15060498450208
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 |