Duns Number:308667539
Device Description: safePICO 23Gx16mm Arterial blood sampler with 23Gx16mm needle, with vented TIPCAP, 1.5 mL, safePICO 23Gx16mm Arterial blood sampler with 23Gx16mm needle, with vented TIPCAP, 1.5 mL, box of 100 pcs.
Catalog Number
956-612
Brand Name
safePICO70
Version/Model Number
956-612
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"
-
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
04dad59d-6456-4643-9e76-d188873b1bb6
Public Version Date
November 27, 2020
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 |