← Back to catalogue
Disposable Overflow Protection / Bacteria filter
FDA UDIClass II (US FDA UDI)
by Medela LLC
Identity
- Trade Name
- Disposable Overflow Protection / Bacteria filter FDA UDI
- Generic Name
- Suction system filter, microbial FDA UDI
- Device Name
- Disposable Overflow Protection / Bacteria filter with Medela connection FDA UDI
- Model / Reference
- 077.0577 FDA UDI
- Description
- Disposable Overflow Protection / Bacteria filter with Medela connection FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07612367011341 FDA UDI
- 510(k) Number
- K130123 FDA UDI
- FDA Product Code
- BTA FDA UDI
- GMDN Term
- Suction system filter, microbial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4780 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Suction system filter, microbial
Disposable Overflow Protection / Bacteria filter by Medela LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Suction system filter, microbial.
- Roscoe Medical — COMPASS HEALTH BRANDS CORP. · Class II
- Roscoe Medical — COMPASS HEALTH BRANDS CORP. · Class II
- AG Industries — AG Industries LLC · Class II
- Allied Medical LLC — Allied Medical LLC · Class II
- BR Surgical, LLC — BR SURGICAL LLC · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Roscoe Medical — COMPASS HEALTH BRANDS CORP. · Class II
- BR Surgical, LLC — BR SURGICAL LLC · Class I
Cleared under the same submission
K130123 also covers:
- Angle piece — Medela LLC
- Angle piece — Medela LLC
- Angle piece yellow DCS — Medela LLC
- Basic — Medela LLC
- Basic — Medela LLC
- Basic portable — Medela LLC
- Basic rack — Medela LLC
- Change-over valve with clampholder and tubing set — Medela LLC
- Clamp holder, plastic — Medela LLC
- Diposable virus / odour Filter — Medela LLC
- Disposable Overflow Protection / Bacteria Odour Filter — Medela LLC
- Disposable Overflow Protection / Virus Filter — Medela LLC
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
- Medela LLC
Sources (1)
- FDA UDI 63aee80c-a539-4bb4-ac1a-ac8790ac9fcd 35 fields · synced May 31, 2026