Identity
- Trade Name
- Calypso Essentials TX 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. The package also contains an adapter for manual pumping as well as spare parts for the pumpset. FDA UDI
- Model / Reference
- 63.00.320 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. The package also contains an adapter for manual pumping as well as spare parts for the pumpset. FDA UDI
Identifiers
- Catalog Number
- 63.00.320 FDA UDI
- Primary DI / UDI-DI
- 00814079021800 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, electric
Calypso Essentials TX by Ardo medical AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ardo medical AG
Sources (1)
- FDA UDI b8c8f2c5-edf9-4d54-aadb-617bb061220b 37 fields · synced Jun 1, 2026