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Blood Centers is a comprehensive, modular, computerized system intended to be used by trained personnel as a tool in the management of data processes performed by staff at blood centers and high-volume testing services. User access to individual modules is controlled through defined access levels. Individual staff may be actively engaged in functions that encompass the following: • Dynamic donor eligibility status • Register, track, and audit donations and deferrals • On-line health history, physical findings, and collection process • Inter-active donor questionnaire (staff and/or donor/remote donor) • HLA/RBC search and match Donor schedules • Component production and modification • Testing • Labeling • Imported Blood Processing • Inventory Management • Distribution • Material Check-In • Offline Data Entry (Re-entry if downtime) • Blood Centers is usable with wired/wireless networks supporting TCP/IP protocols
WELLSKY CORPORATION
2024
In Commercial Distribution
- B10520241 ()
- Blood bank information system application software
The LetsGetChecked Coronavirus (COVID-19) Home Collection Kit is a direct to consumer product for testing of anterior nasal swab specimens collected at home using the LetsGetChecked Coronavirus (COVID-19) Home Collection Kit by any individuals, age 18 years and older (self-collected), 12 years and older (self-collected under adult supervision), or 2 years and older (collected with adult assistance) including individuals without symptoms or other reasons to suspect COVID-19. The LetsGetChecked Coronavirus (COVID-19) Home Collection Kit enables the at-home collection of an anterior nasal swab sample that is then transported to a laboratory designated by LetsGetChecked, Inc. for TMA testing for SARS-CoV-2 with the LetsGetChecked Coronavirus (COVID-19) Test without prescription. The LetsGetChecked Coronavirus (COVID-19) Home Collection Kit may be available direct to consumer (DTC) without a prescription at a physical retail location and online direct to consumer. Activation can only be completed by an adult. When a minor is using the kit, it is activated in a sub-account of the adult. Customers cannot create a sub-account for an infant (<2years). LetsGetChecked HCP will contact all individuals receiving positive and invalid test results. Individuals with negative test results will be notified by email, phone message and through the website portal. For purposes of this EUA, a healthcare provider includes any healthcare professional with prescribing abilities including, but not limited to, physicians, nurses, pharmacists, and laboratory directors. The healthcare provider contacting individuals with test results will have prescribing privileges for that individual, should medication be indicated for treatment.
PRIVAPATH DIAGNOSTICS LIMITED
NO14S, NO15S, NO05S
In Commercial Distribution
- 00860002028095 ()
- Oral/upper respiratory tract specimen collection kit IVD, home-use
The MIS Precision Chevron Bunion System™ is a kit designed to allow surgeons to perform a chevron bunion osteotomy, and subsequent fixation of the osteotomy, with a minimally invasive surgical technique. The MIS Precision Chevron Bunion System™ consists of a single, sterile-packaged SKU that contains both implants and instruments needed for the procedure.
The implants in the kit are cannulated headless compression screws, made from titanium (Ti-6AL-4V ELI). There are two implants in the kit, however only one is used in a surgical procedure. Two implants are provided to allow the physician to select the proper size for the patient at the time of surgery. The implants are 3.5 mm diameter, with lengths of 24 mm and 27 mm.
There are also single-use instruments, made of injection molded polycarbonate, PEEK, and stainless steel included in the MIS Precision Chevron Bunion System™. Instruments include an osteotomy guide (one each for left and right feet), a targeting guide, a screw guide, screwdriver, drill bit, and several K-wires and a guidewire.
Additional general surgical instrumentation is utilized, but not part of the RELJA system, such as sagittal saw, drivers, and scalpel.
Relja Innovations LLC
RI-2427-C
In Commercial Distribution
- 00860005968800 ()
- Orthopaedic bone screw, non-bioabsorbable, sterile
EasyShift Repositioning System V3 for 42" wide mattress, compatible with EasyShift Zipper Sheet
Seneca Devices, Inc.
EAS-42-Z
In Commercial Distribution
- 00860004936817 ()
- Bed mattress support platform, hydraulic
- Intensive-care patient transport system, ventilatory support, neonatal
No Description
BUY SUPPLY INC
PG-IRT1602
In Commercial Distribution
- 00860004330691 ()
- Infrared patient thermometer, ear
No Description
FlexDex Surgical
FD-335 ND
Not in Commercial Distribution
- 00860004002116 ()
- 00860004002109 ()
- Suturing needle holder, single-use
Pump Driver Service Replacement Kit
Breethe, Inc.
001-0301-003
In Commercial Distribution
- 00860001797947 ()
001-0301-003
- Cardiopulmonary bypass system, non-roller type
SubQ It! Bioabsorbable Driver SU-10 is a single-patient use, skin closure device, preloaded with 10 bioabsorbable dermal
fasteners, packaged sterile in a protective foil pouch.
OPUS KSD, INC.
SU-10
In Commercial Distribution
- 10867469000234 ()
- 00867469000237 ()
412010
- Skin stapler/staple, bioabsorbable
SubQ It! Bioabsorbable Driver SU-10 is a single-patient use, skin closure device, preloaded with 10 bioabsorbable dermal fasteners, packaged sterile in a protective foil pouch.
OPUS KSD, INC.
SU-10
In Commercial Distribution
- 10867469000227 ()
- 00867469000220 ()
412010
- Skin stapler/staple, bioabsorbable
REVIAN RED is a non-invasive, hands-free device indicated to treat androgenetic alopecia in both men and women. It is operated via a mobile application to promote hair growth using Modulated Light Therapy (MLT) for a recommended 10-minute daily treatment. REVIAN RED is a system comprised of a wearable soft textile Cap using driver electronics,a rechargeable battery, and integrated light emitting diode (LED) flexible printed circuit board. REVIAN RED is designed as an over-the-counter (OTC) home-based device to treat the entire scalp area of the user and is controlled via a wireless Bluetooth connection to a mobile application operating on a wireless device.
Revian, Inc.
101
In Commercial Distribution
- 00862712000309 ()
- Width: 20 Centimeter
- Weight: 155 Gram
- Length: 22.86 Centimeter
- Height: 15.87 Centimeter
10001
- Hair growth laser device