Identity
- Trade Name
- Vario 18 AC/DC FDA UDI
- Generic Name
- Surgical suction pump FDA UDI
- Device Name
- Powered suction pump FDA UDI
- Model / Reference
- 026.5120 FDA UDI
- Description
- Powered suction pump FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07612367016131 FDA UDI
- 510(k) Number
- K153663 FDA UDI
- FDA Product Code
- BTA FDA UDI
- GMDN Term
- Surgical suction pump 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Surgical suction pump
Vario 18 AC/DC by Medela LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical suction pump.
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- Olympus — Keymed (Medical & Industrial Equipment), Ltd. · Class I
Cleared under the same submission
K153663 also covers:
- Accessories for Vario 18 pump — Medela LLC
- 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 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 6338e076-44a1-4893-bb42-c0227bf18b49 35 fields · synced May 30, 2026