Duns Number:604208868
Device Description: #1602 Blood Draw KitContents: (3) Sponge 2x2 2/Pk, (1) Tourniquet L/F, (1) PVP Prep Pad, ( #1602 Blood Draw KitContents: (3) Sponge 2x2 2/Pk, (1) Tourniquet L/F, (1) PVP Prep Pad, (1) Blood Tube Holder, (1) Blood Collection Tube, (1) Blood Collection Needle, (4) Evidence Seals, (1) Evidence Bag, (1) Biohazard Bag 17x18, (2) Blood Tube Labels, (1) Officer's Report
Catalog Number
1602
Brand Name
Motion Medical Distributing
Version/Model Number
1602
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
OFZ
Product Code Name
Blood Specimen Collection Kit (Excludes Hiv Testing)
Public Device Record Key
128f3997-5d23-450f-a98d-400b64ecc89b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 05, 2017
Package DI Number
25060498450137
Quantity per Package
10
Contains DI Package
15060498450130
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 |