Identity
- Trade Name
- Calypso Essentials Plus FDA UDI
- Generic Name
- Breast pump, electric FDA UDI
- Device Name
- The Calypso breast pump is intended to be used by lactating women to express and collect milk from their breast. It can be used as a single pump and as a double pump. The unit is intended for indoor use only and is intended for single users. FDA UDI
- Model / Reference
- 63.00.287 FDA UDI
- Description
- The Calypso breast pump is intended to be used by lactating women to express and collect milk from their breast. It can be used as a single pump and as a double pump. The unit is intended for indoor use only and is intended for single users. FDA UDI
Identifiers
- Catalog Number
- 63.00.287 FDA UDI
- Primary DI / UDI-DI
- 00814079020964 FDA UDI
- 510(k) Number
- K141742 FDA UDI
- FDA Product Code
- HGX FDA UDI
- GMDN Term
- Breast pump, electric 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Breast pump, electricBreast pump support kit, reusable
Calypso Essentials Plus 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
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- 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 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 Clinic Pumpset — 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 f62c5105-10a0-40ab-babf-8f3ea32315db 37 fields · synced May 30, 2026