DIRECT2 Lid

GUDID 00850034511993

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.

Bimini Technologies LLC

Surgical suction system collection container, reusable
Primary Device ID00850034511993
NIH Device Record Keyeaa32f79-de8c-42ed-b313-b583141d35d9
Commercial Distribution StatusIn Commercial Distribution
Brand NameDIRECT2 Lid
Version Model NumberPVL/PURE2
Company DUNS076649467
Company NameBimini Technologies LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850034511993 [Primary]

FDA Product Code

MDMInstrument, Manual, Surgical, General Use

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850034511993]

Moist Heat or Steam Sterilization


[00850034511993]

Moist Heat or Steam Sterilization


[00850034511993]

Moist Heat or Steam Sterilization


[00850034511993]

Moist Heat or Steam Sterilization


[00850034511993]

Moist Heat or Steam Sterilization


[00850034511993]

Moist Heat or Steam Sterilization


[00850034511993]

Moist Heat or Steam Sterilization


[00850034511993]

Moist Heat or Steam Sterilization


[00850034511993]

Moist Heat or Steam Sterilization


[00850034511993]

Moist Heat or Steam Sterilization


[00850034511993]

Moist Heat or Steam Sterilization


[00850034511993]

Moist Heat or Steam Sterilization


[00850034511993]

Moist Heat or Steam Sterilization


[00850034511993]

Moist Heat or Steam Sterilization


[00850034511993]

Moist Heat or Steam Sterilization


[00850034511993]

Moist Heat or Steam Sterilization


[00850034511993]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-14
Device Publish Date2024-10-04

Devices Manufactured by Bimini Technologies LLC

00850034511993 - DIRECT2 Lid2024-10-14This 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.
00850034511993 - DIRECT2 Lid2024-10-14 This device fits onto the Medela 3000cc Vacuum Canister, an off-the-shelf medical-grade vacuum canister. The DIRECT2 connects an
00850034511009 - Puregraft 850 System Twin Pack2024-08-30 A sterile, single use, closed polyolefin bag contains two polyester meshes and breached by valves for use in harvesting, filteri
00850034511153 - Puregraft Serene Breast Implant2024-04-05 Saline Breast Implant
00850034511337 - Puregraft Serene Breast Implant2024-04-05 Saline Breast Implant
00850034511399 - Puregraft Serene Breast Implant2024-04-05 Saline Breast Implant
00850034511627 - Puregraft Serene Breast Implant2024-04-05 Saline Breast Implant
00850034511658 - Puregraft Serene Breast Implant2024-04-05 Saline Breast Implant
00850034511672 - Puregraft Serene Breast Implant2024-04-05 Saline Breast Implant

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