Duns Number:543007373
Device Description: A sharp bevel-edged, hollow tubular metal instrument intended to be used as part of a bloo A sharp bevel-edged, hollow tubular metal instrument intended to be used as part of a blood collection set for drawing blood from a patient. It is intended to be connected to blood collection tubing and/or a blood collection Luer connector for transfer into a blood specimen receptacle. It may include a pre-attached blood collection tube spike however it does not include a blood collection tube holder. This is a single-use device.
Catalog Number
MER2021
Brand Name
Multi-Sample Blood Collection Set
Version/Model Number
21G x 3/4"
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
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
K202188,K202188,K202188
Product Code
JKA
Product Code Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Public Device Record Key
be7064a3-2dc2-4eeb-b5a4-3a8b01c15013
Public Version Date
August 09, 2021
Public Version Number
1
DI Record Publish Date
July 31, 2021
Package DI Number
16958697602971
Quantity per Package
50
Contains DI Package
06958697602974
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-