Identity
- Trade Name
- Calypso Pro Complete FDA UDI
- Generic Name
- Breast pump, electric FDA UDI
- Device Name
- The Calypso Pro Electrical Breast Pump is intended to be used by lactating women to express and collect milk from theis breast. It can be used as a single and as double pump. The unit is intended for indoor use only and is intended for multiple users. FDA UDI
- Model / Reference
- 63.00.336 FDA UDI
- Description
- The Calypso Pro Electrical Breast Pump is intended to be used by lactating women to express and collect milk from theis breast. It can be used as a single and as double pump. The unit is intended for indoor use only and is intended for multiple users. FDA UDI
Identifiers
- Catalog Number
- 63.00.336 FDA UDI
- Primary DI / UDI-DI
- 00814079021992 FDA UDI
- 510(k) Number
- K150721 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 Pro Complete 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
K150721 also covers:
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 1ccee2dc-0779-47ed-b451-26083c53805f 37 fields · synced May 30, 2026