AlPep LLC’s FDA Registration Number is 3023230882, and 2022 FDA Owner Operator Number is 10085596.  The UniSUC FDA Listing Number is D477174.  UniSUC is a Class I product and it qualifies to be exempt from the FDA premarket notification [501(K)] requirements. 

We recommend changing every 12-24 hours or as needed.  For healthcare work, we recommend changes every 8-12hours (per shift) or as needed if the device is deemed to be unclean.  Please note however, since UniSUC is comprised of 2 components, the Frame Device and the Liner, the Frame device is REUSABLE and needs only a quick rinse during a change cycle.  The LINER is the DISPOSABLE component which needs complete replacement during the recommended change cycle.  

 The UniSUC Frame is intended to be reusable for the patient it gets assigned to.  Each UniSUC frame has a printed stamp area where the patient’s name can be written (or labeled) onto along with the date and initials of the caregiver applying the Frame Device.  This ensures the UniSUC Frame can be identified for 1 specific patient only and not inadvertently used on other patients.  During the recommended changes (every 8-12hrs, every shift change, or if the device is soiled), only the disposable Liner is discarded during replacement, and the Frame is reused.  The Frame can be cleaned/rinsed simply with soap and water or a disinfectant wipe.  However, if the Frame is stained and/or possibly clogged with feces/stool, it should be replaced with a new one.

The liner will be wet at initial urine discharge but will immediately be siphoned away from the patient. With the continuous airflow resulting from the integrated suction, the “umbrella-like” design of the liner ultimately controls the airflow intake from the perimeter of the device, particularly on the lower abdomen at pubis level where the frame device is looser. The advantage is airflow distribution from lower abdomen towards below perineal area of the patient. This function to pull moisture away from skin promotes aeration on the skin. With an expansive airflow distribution, the resulting effect of keeping patients dry is enhanced, which is a significant benefit for the patient’s healing process.

The UniSUC Frame Device and Liner System is designed to work with any canister size continuously; its capacity to continuously siphon fluids from the patient is only limited by the size of the suction source fluid canister size/capacity that the Frame Device is attached to.  The vacuum port of Frame Device is a tapered design so it can accommodate for a range of standard medical vacuum attachment sizes in imperial/us or metric units; specifically tubing attachments with 1/4”-3/8” ID or 6.4mm-9.5mm ID.  The length of the vacuum tubing has no effect on UniSUC’s system function or performance.  Any Hospital’s standard 1200cc Canister and Vacuum hose system is compatible with the UniSUC System.  Please watch the following video using a similar vacuum canister & hose supplied by Medline:  https://youtu.be/O-1Agxrf0ac

We currently do not yet have lifetime testing data available for the UniSUC Frame Device.  However, because the Frame device is made of very soft Medical Grade PVC material integrated with 12-gauge copper wiring, giving it shape memory and flexibility, it will not crack or break after repeated flexing/shaping during normal use for the lifetime of the Frame Device.  If any defects or quality issues are found with any Frame Device, AlPep LLC will replace it free of charge.

Yes, UniSUC is 100% compatible with PureWick’s Suction Machine along with many other Medical Suction Machines/Devices; UniSUC is intended to be a replacement for the PureWick external catheter for females and in addition, it can be used by males as well.

Currently, AlPep LLC nor our UniSUC device is not a Medicare or Medicaid enrolled participating supplier.  However, depending on your specific coverage, you may try the following codes:

CPT/HCPCS Code  E0600  (Description –  RESPIRATORY SUCTION PUMP, HOME MODEL, PORTABLE OR STATIONARY, ELECTRIC )

HCPCS code K1006 (SUCTION PUMP, HOME MODEL, PORTABLE OR STATIONARY, ELECTRIC, ANY TYPE, FOR USE WITH EXTERNAL URINE MANAGEMENT SYSTEM)

HCPCS code A9999 (MISCELLANEOUS DME SUPPLY OR ACCESSORY, NOT OTHERWISE SPECIFIED; )

HCPCS code A6590 (EXTERNAL URINARY CATHETERS; DISPOSABLE, WITH WICKING MATERIAL, FOR USE WITH SUCTION PUMP, PER MONTH)

HCPCS code A7001 (CANISTER, NON-DISPOSABLE, USED WITH SUCTION PUMP, EACH)

HCPCS code A7002 (TUBING, USED WITH SUCTION PUMP, EACH)

We recommend changing the liner every 12-24hrs The frame device is reusable and only requires rinsing/washing with soap and water or wipe down with disinfectant wipes.

Yes. For side sleepers, UniSUC works best if the user is propped up (via pillows or adjustable bed) at a 20-30 degree angle to ensure the fluids flow in the correct direction towards the bottom tip of the device.

To start using our system, you will need to purchase the following:

• UniSUC STARTER PACK (SKU# ALPP-US-22K1-1)
• If you don’t have your own suction machine (such as PureWick’s machine), you can purchase one of our High Volume Medical Suction Packages
  • High Volume Medical Suction Package (2000cc Screw-on Lid) – SKU# ALPP-US-23MS3A-1 
  • High Volume Medical Suction Package (2000cc Snap-on Lid) – SKU# ALPP-US-23MS3A-1

Yes, it will work great for a wheelchair bound patient! It will work optimally for patients in the sitting position.

The UniSUC STARTER PACK comes with a Right-Handed Vacuum port on the frame as standard. However, we have recently just made available for customers to order a Left-Handed version (Vacuum Port attachment on the left side of the frame):

• SKU# ALPP-US-22K1LH-1