FDA.reportPublic FDA data

DIRECT2 Lid

Primary DI
00850034511993
Brand
DIRECT2 Lid
Company
Bimini Technologies LLC
Model
PVL/PURE2
Device description
This device fits onto the Medela 3000cc Vacuum Canister, an off-the-shelf medical-grade vacuum canister. The DIRECT2 connects an external suction source to the Medela Vacuum Canister. Bimini Health Tech provides these products for use with the Puregraft 850 for vacuum-harvesting large volumes of adipose tissue directly into the bag.
Published
2024-10-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850034511993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850034511993008500345119938500345119930850034511993

GMDN Terms#

Term, Definition table
TermDefinition
Surgical suction system collection container, reusableA sealable container (e.g., cylindrical, bottle-shaped, pouch) intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues, calculi) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., tissue or polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
076649467
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850034511047Puregraft SYNCPURE/SYNC2026-02-24
00850034511023Puregraft 850 System Twin Pack850/TWIN2024-08-22
00850034511108Puregraft 50 System50/PURE2022-04-01
00850034511139Puregraft 250 System250/PURE2022-04-01
00850034511177Puregraft 250 System250/PURE2022-04-01
00850034511191Puregraft 850 System850/PURE2022-04-01
00850034511696Puregraft 50 System50/PURE2024-01-11
00850034511252Dermapose RefreshREFRESH2022-02-09
00850034511276AutoPose RestoreABS-101035-12022-02-09
00850034511009Puregraft 850 System Twin Pack850/TWIN2024-08-22
00850034511436Puregraft Serene Breast Implant335CC2024-03-28
00850034511092Puregraft Serene Breast Implant210CC2024-03-28
00850034511283Puregraft Serene Breast Implant270CC2024-03-28
00850034511368Puregraft Serene Breast Implant300CC2024-03-28
00850034511641Puregraft Serene Breast Implant370CC2024-03-28
00850034511665Puregraft Serene Breast Implant405CC2024-03-28
00850034511689Puregraft Serene Breast Implant440CC2024-03-28
00850034511764Puregraft Serene Breast Implant475CC2024-03-28
00850034511788Puregraft Serene Breast Implant515CC2024-03-28
00850034511818Puregraft Serene Breast Implant555CC2024-03-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776422806MillenniumAvalign Technologies, Inc.MDM2026-08-03
00198506092350ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-29
00198506093197ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-29
00198506093586ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-29
00198506090561ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506092589ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506092671ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506092695ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506092701ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506092718ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506092725ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093012ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093029ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093111ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093166ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093203ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093296ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093364ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093371ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093425ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093432ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093463ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506092039ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-27
00198506092046ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-27
00198506092398ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-27
00198506092404ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-27
00198506092411ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-27
00198506092428ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-27
00840456202104JMUJMU DENTAL, INCMDM2026-07-27
00840456215760JMUJMU DENTAL, INCMDM2026-07-27