Duns Number:315654579
Device Description: For Collection and Filtration of up to 1.2 Liters of Aspirated Bone Marrow. Must be used w For Collection and Filtration of up to 1.2 Liters of Aspirated Bone Marrow. Must be used with the Bone Marrow Collection Stand.
Catalog Number
X6R2107
Brand Name
Bone Marrow Collection Kit with Flexible Pre-Filter and Inline Filters
Version/Model Number
X6R2107
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LWE
Product Code Name
Bone Marrow Collection/Transfusion Kit
Public Device Record Key
2a2ddeae-a305-4526-b790-46c01590788a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 05, 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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 87 |
| U | Unclassified | 2 |