Identity
- Trade Name
- Accessories for Vario 18 pump FDA UDI
- Generic Name
- Suction/irrigation tubing, single-use FDA UDI
- Device Name
- Accessories for Vario 18 pump consisting of disposable tubing (077.0952) FDA UDI
- Model / Reference
- 080.0008 FDA UDI
- Description
- Accessories for Vario 18 pump consisting of disposable tubing (077.0952) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07612367022910 FDA UDI
- 510(k) Number
- K153663 FDA UDI
- FDA Product Code
- BTA FDA UDIHDB FDA UDIMUU FDA UDI
- GMDN Term
- Suction/irrigation tubing, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4780 FDA UDI884.4340 FDA UDI878.5040 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Suction/irrigation tubing, single-use
Accessories for Vario 18 pump by Medela LLC — Class II — FDA UDI — listed in FDA GUDID — 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
K153663 also covers:
- Accessories for Vario 18 pump — Medela LLC
- Adapter Vario — Medela LLC
- Angle piece Orange DCS — Medela LLC
- Angle piece yellow DCS — Medela LLC
- Given Vario Pump Kit — Medela LLC
- Locking Clasp DCS — Medela LLC
- Vario 18 AC — Medela LLC
- Vario 18 AC — Medela LLC
- Vario 18 AC — Medela LLC
- Vario 18 AC — Medela LLC
- Vario 18 AC/DC — Medela LLC
- Vario 18 c/i AC/DC — 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 |
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Manufacturer
- Manufacturer
- Medela LLC
Sources (1)
- FDA UDI 334330f5-fae5-489e-b0ac-ac34f7ac6f2c 35 fields · synced May 30, 2026