Duns Number:544543513
Device Description: The Safety blood collection sets are intended to be used with vacuum blood collection tube The Safety blood collection sets are intended to be used with vacuum blood collection tube for venipuncture to collect blood specimens from patients, and the safety sheath is designed to aid in the reduction of accidental needlesticks.
Catalog Number
BC032375
Brand Name
CAINA
Version/Model Number
23G*3/4"*12"
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K151991,K151991,K151991
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
8d5c7144-12a2-47cc-b968-d77e6ea96ac8
Public Version Date
September 12, 2022
Public Version Number
1
DI Record Publish Date
September 02, 2022
Package DI Number
16971564466049
Quantity per Package
50
Contains DI Package
06971564466042
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-