Identity
- Trade Name
- DIRECT2 Lid FDA UDI
- Generic Name
- Surgical suction system collection container, reusable FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- PVL/PURE2 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850034511993 FDA UDI
- FDA Product Code
- MDM FDA UDI
- GMDN Term
- Surgical suction system collection container, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical suction system collection container, reusable
DIRECT2 Lid by Bimini Technologies LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Allied Medical LLC — Allied Medical LLC · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bimini Technologies LLC
Sources (1)
- FDA UDI eaa32f79-de8c-42ed-b313-b583141d35d9 33 fields · synced May 31, 2026