Identity
- Trade Name
- Double Clinic Pumpset FDA UDI
- Generic Name
- Breast pump support kit, reusable FDA UDI
- Device Name
- The Ardo Pumpset should be used in combination with Ardo breastpumps and is intended to be used by lactating women to express and collect milk from their breast. The Pumpset can be used both as a single pumpset and as a double pumpset and is intented for single users only. FDA UDI
- Model / Reference
- 63.00.555 FDA UDI
- Description
- The Ardo Pumpset should be used in combination with Ardo breastpumps and is intended to be used by lactating women to express and collect milk from their breast. The Pumpset can be used both as a single pumpset and as a double pumpset and is intented for single users only. FDA UDI
Identifiers
- Catalog Number
- 63.00.555 FDA UDI
- Primary DI / UDI-DI
- 00814079022203 FDA UDI
- 510(k) Number
- K141742 FDA UDI
- FDA Product Code
- HGX FDA UDI
- GMDN Term
- Breast pump support kit, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.5160 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
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Category: Breast pump, electricBreast pump support kit, reusable
Double Clinic Pumpset by Ardo medical AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Breast pump support kit, reusable.
- Spectra — Uzinmedicare Co., Ltd. · Class II
- Maymom Double Flange Set for Medela Pump in Style Advanced Pump, 21 mm — MAYMOM LLC · Class II
- Spectra — Uzinmedicare Co., Ltd. · Class II
- Spectra — Uzinmedicare Co., Ltd. · Class II
- Unimom — Unimom.Co · Class II
- PNSMX Resupply kits — Medela LLC · Class II
- Hands-free Breast shields, 24mm — Medela LLC · Class II
- Spectra — Uzinmedicare Co., Ltd. · Class II
Cleared under the same submission
K141742 also covers:
- Calypso Double Plus — Ardo medical AG
- Calypso Essentials — Ardo medical AG
- Calypso Essentials Plus — Ardo medical AG
- Calypso Essentials TX — Ardo medical AG
- Calypso Pump Unit — Ardo medical AG
- Calypso To Go Pure — Ardo medical AG
- Calypso To Go Pure TX — Ardo medical AG
- Calypso-To-Go — Ardo medical AG
- Carum — Ardo medical AG
- Carum — Ardo medical AG
- Carum Battery — Ardo medical AG
- Double Pumping Collection Kit — Ardo medical AG
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
- Ardo medical AG
Sources (1)
- FDA UDI c2ddb9e5-fdce-40c2-a332-e6c2f8cb93d0 36 fields · synced May 30, 2026