Duns Number:831375089
Device Description: Color: PinkInstructions for use1. Twist off the protective cap and pull it straight out.2 Color: PinkInstructions for use1. Twist off the protective cap and pull it straight out.2. Press the safety lancet body firmly against the puncture site to activate the device.3. Gently apply intermittent pressure near the puncture site to obtain the required blood volume.Warnings1. Do not use if protective cap has been previously removed from lancet.2. Clean the injection site prior to use following established procedure.3. Discard used lancet into a sharps container in accordance with facility guidelines, national and state regulations.
Catalog Number
7551
Brand Name
PremierPro Lancet
Version/Model Number
7551
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
FMK
Product Code Name
Lancet, Blood
Public Device Record Key
19758ccf-32e9-4c87-8a07-323dfe432f3b
Public Version Date
February 15, 2019
Public Version Number
2
DI Record Publish Date
August 03, 2018
Package DI Number
10811220030350
Quantity per Package
100
Contains DI Package
00811220030353
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 | 486 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 177 |
| U | Unclassified | 1 |