Identity
- Trade Name
- AVENIO Millisect Fill Station FDA UDI
- Generic Name
- Laboratory waste receptacle IVD FDA UDI
- Model / Reference
- 08106533001 FDA UDI
Identifiers
- Catalog Number
- 08106533001 FDA UDI
- Primary DI / UDI-DI
- 07613336146613 FDA UDI
- FDA Product Code
- LXG FDA UDI
- GMDN Term
- Laboratory waste receptacle IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Laboratory waste receptacle IVD
AVENIO Millisect Fill Station by Roche Molecular Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Laboratory waste receptacle IVD.
- ELITe InGenius® Waste Box — ELITECHGROUP INC. · Class II
- Alinity m — Abbott Molecular · Class II
- Alinity m — Abbott Molecular · Class II
- Curaplex — BOUND TREE MEDICAL, LLC · Class I
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- NovaSeq™ 6000Dx Library Tube — Illumina, Inc. · Class I
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- Curaplex — BOUND TREE MEDICAL, LLC · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Roche Molecular Systems, Inc.
Sources (1)
- FDA UDI a4377cc1-f93d-4ee7-b649-ec2906454c2b 33 fields · synced Jun 9, 2026