Duns Number:076649467
Device Description: This device fits onto the Medela 3000cc Vacuum Canister, an off-the-shelf medical-grade va This device fits onto the Medela 3000cc Vacuum Canister, an off-the-shelf medical-grade vacuum canister. The Vacuum Lid connects an external suction source to the Medela Vacuum Canister. Bimini Health Tech provides these products for use with the Puregraft 250 or Puregraft 850 for vacuum-harvesting large volumes of adipose tissue directly into the bag.
Catalog Number
-
Brand Name
Puregraft Vacuum Lid
Version/Model Number
PVL/PURE
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
-
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
MDM
Product Code Name
Instrument, Manual, Surgical, General Use
Public Device Record Key
42e41caf-0580-4a83-a4b4-4cac5c42fedf
Public Version Date
February 17, 2022
Public Version Number
1
DI Record Publish Date
February 09, 2022
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 17 |