Identity
- Trade Name
- Puregraft Vacuum Lid FDA UDI
- Generic Name
- Surgical suction system collection container, reusable FDA UDI
- Device Name
- Vacuum Lid EUDAMEDThis 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. FDA UDI
- Model / Reference
- PVL/PURE EUDAMEDFDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850034511054 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850034511PVLZL EUDAMED
- Direct Marketing DI
- 00850034511054 EUDAMED
- FDA Product Code
- MDM FDA UDI
- EMDN Code
- L250399 LIPOSUCTION INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical suction system collection container, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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: Ultrasonic surgical system generator
Vacuum Lid by Bimini Health Tech — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850034511PVLZL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bimini Health Tech
- EUDAMED SRN
- US-MF-000008649
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 060b1c77-fd14-4a2a-ba28-5cbd1539fd57 61 fields · synced Jul 9, 2026
- FDA UDI 42e41caf-0580-4a83-a4b4-4cac5c42fedf 33 fields · synced May 30, 2026