Calypso Pro Pump Unit
The ARDO Calypso Pro pump unit uses a single piston mechanism to generate suction for expressing breast milk. With a compatible pump set, it can operate for one breast or both breasts…
The ARDO Calypso Pro pump unit uses a single piston mechanism to generate suction for expressing breast milk. With a compatible pump set, it can operate for one breast or both breasts simultaneously. It is intended for indoor hospital, rental or personal use and is suitable for multiple users.
Vacuum and cycle frequency can be adjusted independently using the keyboard and LCD display. Changing the cycle setting does not change the selected vacuum level, and changing the vacuum setting does not change the cycle level.
Listed Item
The Calypso Pro breastpump 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 multiple users.
Power and Pumping Range
The unit can use an outlet adapter, car battery supply or optional batteries. The expression range is 37 to 250 mmHg at 30 to 60 cycles per minute. A single suction connection supports double pumping through a Y connector.
Who Else Makes It
Concentrated in Guangdong (28), Zhejiang (5), Hong Kong (2). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Essentia Industries Ltd. | Dong Guan | Guangdong | Contract manufacturer | 31 |
| Alleva Medical (D.G.) Ltd | Dongguan | Guangdong | Contract manufacturer | 13 |
| Joytech Healthcare Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 9 |
| JDI Electronics Factory | Dongguan | Guangdong | Contract manufacturer | 7 |
| Guangdong Xinbao Electrical Appliances Holdings Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 6 |
| Jiangsu Xinbei Electrical Appliances Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 6 |
| Shenzhen Jingxintai Houseware Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Huizhou LVB Maternal AND Infant Supplies Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 3 |
| Huizhou Sunwinon Electronics Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 3 |
| Mastars Industries Co., Ltd. | Guangdong | Guangdong | Contract manufacturer | 3 |
| Rrdonnelley | Dongguan | Guangdong | Contract manufacturer | 3 |
| SFY Intelligent Technology (Suzhou) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 3 |
Showing 12 of 40. All 40 manufacturers in China registered for Pump, Breast, Powered
Record
| Listed by | Ardo Medical AG, Switzerland |
|---|---|
| FDA product code | HGX |
| Device type | Pump, Breast, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 884.5160 |
| Establishment | Manufacturer |
| 510(k) | K150721 |
| Record published | 2016-09-22 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | serial number |
| Storage | Storage environment temperature -20 to 70 °C; Storage environment humidity 0 to 93 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal; Handling environment temperature 5 to 40 °C; Handling environment humidity 30 to 75 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal |
| Packaging | Box of 32 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 63.00.286 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Spectra | Uzinmedicare Co., Ltd. | 144 |
| Freemie | Dao Health | 93 |
| Ameda, Inc. | Ameda, Inc. | 72 |
| Motif Medical | Cimilre Co., Ltd. | 47 |
| Momcozy | Shenzhen Root Innovation Technology Co., Ltd. | 44 |
| Symmetrical Health, LLC | Cimilre Co., Ltd. | 28 |
| Electric Breast Pump | Ningbo Huiyoo Baby Products Co., Ltd. | 28 |
| Ameda® | Cimilre Co., Ltd. | 22 |
| LVB | Huizhou LVB Maternal & Infant Supplies Co., Ltd. | 17 |
| Vive | Vive Health LLC | 17 |
| ViveCare | Vive Health LLC | 16 |
| Stella Baby USA | Cimilre Co., Ltd. | 15 |
Showing 12 of 307. All products under Pump, Breast, Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K230590 | 2023-03-30 |
| K212773 | 2022-04-15 |
| K172067 | 2017-11-29 |
| K150721 | 2015-06-17 |
| K141742 | 2014-10-17 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.