Duns Number:308667539
Device Description: PICO70 23gx32mm Arterial blood sampler w. 23gx32mm needle, 1.5 mL, box of 100 units
Catalog Number
956-534
Brand Name
PICO70
Version/Model Number
956-534
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 24, 2021
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"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JKA
Product Code Name
Tubes, vials, systems, serum separators, blood collection
Public Device Record Key
eb776652-5a53-46ce-ad8a-edd03bc08544
Public Version Date
September 16, 2022
Public Version Number
3
DI Record Publish Date
September 01, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 124 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 66 |