Identity
- Trade Name
- Biofill applicator FDA UDI
- Generic Name
- Surgical irrigation/aspiration tubing set FDA UDI
- Device Name
- Biofill applicator, accessory for body-jet evo/eco; suitable for Biofill cannulas (15 cm), Single-use FDA UDI
- Model / Reference
- Single-use Biofill Applicator for body-jet evo and body-jet eco, L=300, for 15 c FDA UDI
- Description
- Biofill applicator, accessory for body-jet evo/eco; suitable for Biofill cannulas (15 cm), Single-use FDA UDI
Identifiers
- Catalog Number
- 580001-5 FDA UDI
- Primary DI / UDI-DI
- 04260170881151 FDA UDI
- 510(k) Number
- K082025 FDA UDI
- FDA Product Code
- QPB FDA UDI
- GMDN Term
- Surgical irrigation/aspiration tubing set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical irrigation/aspiration tubing set
Biofill applicator by Human Med AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical irrigation/aspiration tubing set.
- LAMIS Tubing — Mentor Texas LP · Class I
- Aspiration Tubing — BLACK & BLACK SURGICAL, INC. · Class II
- MB ULTRA-LIMP TUBING — The Wells Johnson Company · Class II
- INFILTRATION TUBING — BLACK & BLACK SURGICAL, INC. · Class II
- Autofuse Tubing — Mentor Texas LP · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- ENDOFLOW II - PROBES - 4 holes diam.5 inch — Promepla · Class I
- Hysteroscopy set 2 spikes — Promepla · Class II
Cleared under the same submission
K082025 also covers:
- Biofill Cannula — Human Med AG
- Biofill Cannula — Human Med AG
- Biofill Cannula — Human Med AG
- Biofill Infiltration Cannula — Human Med AG
- Biofill cannula — Human Med AG
- Biofill cannula — Human Med AG
- Biofill cannula — Human Med AG
- Biofill cannula, RAPID — Human Med AG
- Biofill infiltration cannula — Human Med AG
- Hydrophobic Filter-set — Human Med AG
- Hydrophobic Filter-set — Human Med AG
- Hydrophobic Filter-set — Human Med AG
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Human Med AG
Sources (1)
- FDA UDI 2311b0ea-ced0-4d3d-9b47-2c1e4c5baaf9 37 fields · synced May 30, 2026