Duns Number:308667539
Device Description: safePICO Aspirator Arterial blood sampler. Aspirator only with vented TIPCAP, 1.5 mL, box safePICO Aspirator Arterial blood sampler. Aspirator only with vented TIPCAP, 1.5 mL, box of 100 pcs.
Catalog Number
956-622
Brand Name
safePICO Aspirator
Version/Model Number
956-622
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
1c2ca511-6abe-4eb2-8c4f-510e88fccad6
Public Version Date
November 27, 2020
Public Version Number
4
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 |