Duns Number:265492868
Device Description: 500 mL Phlebotomy Bag with Needle.
Catalog Number
MRV6000LD
Brand Name
MRV6000LD - Therapeutic Phlebotomy Bag w/Needle
Version/Model Number
MRV
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 02, 2019
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
BK030008,BK030008
Product Code
CAK
Product Code Name
Microfilter, Blood Transfusion
Public Device Record Key
a93ed5a4-c757-4d4d-ba7a-99e108569f7a
Public Version Date
November 04, 2019
Public Version Number
4
DI Record Publish Date
September 22, 2016
Package DI Number
13567051503125
Quantity per Package
20
Contains DI Package
03567051503128
Package Discontinue Date
November 02, 2019
Package Status
Not in Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 6 |
2 | A medical device with a moderate to high risk that requires special controls. | 9 |