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510(k) Data Aggregation
(262 days)
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(154 days)
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(154 days)
The Spectra Platinum is a single-user, powered breast pump intended to express and collect milk from the breasts of lactating women.
The Spectra Platinum is an electrically powered breast pump intended for use by lactating women to stimulate lactation and express breast milk. The device is intended for single-user, home use. Pumping can be performed on one breast (single pumping) or both breasts (double pumping) at the same time.
The Spectra Platinum operate using an AC adapter (100-240V AC, 50/60Hz, DC 12V) or a rechargeable Li-Polymer battery (11.1V, 2,000mAh).
The Spectra Platinum is comprised of the following components: Main unit, Power adapter, Tubing, Backflow protector, Wide breast shield, Milk bottle, Screw ring, Cap, Sealing cap for milk bottle, Silicone nipple, Silicone valve. The device is provided non-sterile.
The Spectra Platinum support a single pumping mode in which only one breast is expressed and a dual pumping mode in which both breasts are expressed. The user can switch between Massage Mode and Expression Mode using designated buttons and adjust the vacuum level and cycle speed within each mode.
Spectra Platinum includes the following features:
- Expression can be performed on one breast only (single mode), on both sides simultaneously (dual mode).
- Expression mode: 1-15 level (90-270 mmHg), cycle speeds (38, 42, 46, 50, 54)
- Massage mode: 1-5 level (60-100 mmHg), cycle speeds (70, 80, 90, 100, 105)
The Spectra Platinum operates within these specified parameters.
When the backflow protector is assembled between the pump unit and the wide breast shield, the silicone membrane inside the backflow protector creates a hygienic barrier by preventing air and milk from flowing back into the pump unit. This not only enables safe and hygienic breast pumping, but also protects the pump unit from contamination and potential damage caused by backflow of milk.
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(119 days)
ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150)
ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150) is a contrast media management system that is indicated for the controlled, automatic administration, on the venous side, of contrast media and saline (NaCl), to human subjects undergoing diagnostic examinations in magnetic resonance (MR) applications.
ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150) is specifically indicated for use in MRI procedures for the delivery of the following contrast media:
- Gadobutrol Injection in single-dose (SD) container or Imaging Bulk Package (IBP)
- Gadopiclenol Injection in SD container or IBP
- Gadobenate dimeglumine Injection in SD container
- Gadoterate meglumine Injection in SD container
Easy-Click-Cassette – flex Max 2M and Easy-Click-Cassette – flex Max 3 are used for a maximum time of twenty-four (24) hours or a maximum of 96 bottles of contrast media, whichever comes first.
Use time expiration per SD container is a maximum of four (4) hours, unless otherwise stated by the contrast media labeling.
Use time expiration per IBP or saline container is a maximum of twenty-four (24) hours, unless otherwise stated by the media labeling.
Spike for MRI disposable is for single-bottle use only and must be discarded with the media container. The Patient tubing must be discarded after each patient procedure.
ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150) is to be used only by and under quasi-continuous supervision of trained healthcare professionals in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravascular administration of contrast agent.
The ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150) is not intended for injection of contrast media (CM) for high-pressure angiography.
ulricheasyINJECT Max 3 (XD 10180)
ulricheasyINJECT Max 3 (XD 10180) is a contrast media management system that is indicated for the controlled, automatic administration, on the venous side, of contrast media and saline (NaCl), to human subjects undergoing diagnostic examinations in magnetic resonance (MR) applications.
ulricheasyINJECT Max 3 (XD 10180) is specifically indicated for use in MRI procedures for the delivery of the following contrast media:
- Gadobutrol Injection in single-dose (SD) container or Imaging Bulk Package (IBP)
- Gadopiclenol Injection in SD container or IBP
- Gadobenate dimeglumine Injection in SD container
- Gadoterate meglumine Injection in SD container
ulricheasyINJECT Max is a syringeless contrast media management system that is designed for the controlled, automatic venous administration of contrast media in conjunction with physiological saline solution to human subjects undergoing diagnostic examinations in Magnetic Resonance Imaging (MRI or PET MRI).
The ulricheasyINJECT Max device consists of a terminal, injector, and tubing system. The injector is a mobile pedestal device that consists of an injector head and injector base with rechargeable battery. The tubing system is the only component that comes in contact with the patient and has indirect contact with the blood path of a patient for a limited duration (few minutes). The tubing system consists of the following three components:
- Spikes,
- Easy-Click-Cassette – flex
- Patient Tubing
The ulricheasyINJECT Max uses a peristaltic pump as part of the injector which is designed to transport the media fluid through the tubing system (spikes, cassette, and patient tubing). ulricheasyINJECT Max is intended to be used with the following components that are not supplied with the system:
- Saline containers,
- Single-dose contrast media bottles,
- Imaging Bulk Package (IBP) contrast media containers, and
- Cannula.
ulricheasyINJECT Max is equipped with multiple hardware and software controls that work together for the safe operation of the intended use of the system. Controls include air detectors to detect the presence of air in the tubing system without direct contact with the medium, pressure controls to manage and regulate pressure inside the tubing system, and check valves to prevent backflow of media and avoid retrograde contamination.
The ulricheasyINJECT Max is provided in three models:
- ulricheasyINJECT Max 2M (XD 10140),
- ulricheasyINJECT Max 3 (XD 10150), and
- ulricheasyINJECT Max 3 (XD 10180).
The Max 3 models have 3 media connection points: 1 NaCl and 2 Contrast Media connections. The Max 2M has 2 media connection points: 1 NaCl and 1 Contrast Media connections. Max 2M and Max 3 are technically identical except the different available media connection points.
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(169 days)
Unimed Reusable SpO2 Sensors are indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) in adult patients weighing greater than 30 kg who are either well or poorly perfused. The device is intended for use under no-motion conditions in professional healthcare environments. These devices are for prescription use only.
The subject device is Unimed Reusable SpO2 Sensors intended for non-invasive measurement of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) in clinical settings. The sensor is designed for compatibility with CSI 8100EP1, and is supplied non-sterile.
The sensor consists of a connector, a cable, and a finger clip housing incorporating a light-emitting diode (LED) and photodetector (PD). The subject device operates on the same principle and share similar design features, materials, and performance characteristics as the predicate device.
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(169 days)
Unimed Reusable SpO2 Sensors are indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) in adult patients weighing greater than 30 kg who are either well or poorly perfused. The device is intended for use under no-motion conditions in professional healthcare environments. These devices are for prescription use only.
The subject device (U403S-06) is Unimed Reusable SpO2 Sensor and are fully compatible for use with BCI SPECTRO2 10. The sensor is supplied non-sterile.
The subject sensor consists of a plug/connector (BCI DB9 sensor connector), a cable (1.1 m), and a patient-contacting sensor (soft tip: U403S-06) where light-emitting diode (LED) and photodetector (PD) are located. The subject sensor shares the same principle of operation as the predicate device for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) measurements. Also, the subject sensor has identical material composition and performance characteristics to the predicate device.
The purpose of the submission is to receive clearance to market U403S-06 under their own 510k.
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