Identity
- Trade Name
- Coupling piece FDA UDI
- Generic Name
- Suction/irrigation tubing, single-use FDA UDI
- Device Name
- Connectors and Tubings EUDAMEDCoupling Piece for tubing FDA UDI
- Model / Reference
- 077.1018 EUDAMEDFDA UDI
- Description
- Coupling Piece for tubing FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07612367008327 EUDAMEDFDA UDI
- Basic UDI-DI
- 07612367mjvfhlNN EUDAMED
- 510(k) Number
- K130123 FDA UDI
- FDA Product Code
- BTA FDA UDI
- EMDN Code
- A070199 ADAPTERS AND CONNECTORS - OTHER EUDAMED
- GMDN Term
- Suction/irrigation tubing, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4780 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
No
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
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/irrigation tubing, single-use
Coupling piece by Medela LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Suction/irrigation tubing, single-use.
- Non-sterile aspiration tubes — Produtos Médicos Hospitalares, SA · Class I
- AMSure® Suction Connecting Tube with Pre-Attached Yankauer — AMSINO INTERNATIONAL, INC. · Class II
- ENT-single-use suction tubes, angled — Spiggle & Theis Medizintechnik GmbH · Class II
- ENT-single-use suction tubes, angled — Spiggle & Theis Medizintechnik GmbH · Class II
- Bioseal Inc. — BIOSEAL · Class I
- Conneting tube — Grena (Qingdao) Medical Devices Ltd. · Class I
- Suction Tube Ch 24, 350 cm — Dispo Medical B.V. · Class I
- Bioseal Inc. — BIOSEAL · 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 / Bacteria filter — Medela LLC
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medela LLC
Sources (2)
- FDA UDI e42577b5-d669-49cd-8c2c-e95f9851db05 35 fields · synced Aug 1, 2026
- EUDAMED a55934b1-ccb4-47cd-9732-6d31e60b4d0d 61 fields · synced Aug 1, 2026