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LifeTrak 2012 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
2012
In Commercial Distribution
- B105LIFETRAK0 ()
- Blood bank information system application software
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
2023
In Commercial Distribution
- B105BLOODCENTERS2023 ()
- Blood bank information system application software
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
2019
In Commercial Distribution
- B105BLOODCENTERS2019 ()
- Blood bank information system application software
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
2018
In Commercial Distribution
- B105BLOODCENTERS2018 ()
- Blood bank information system application software
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
2022
In Commercial Distribution
- B105BLOODCENTERS0 ()
- Blood bank information system application software
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
Dynesys® TL Hex Driver
ZIMMER SPINE, INC.
07.00737.701
In Commercial Distribution
- 00880304989368 ()
07.00737.701
- Orthopaedic surgical procedure kit, non-medicated, reusable
No Description
Laboratoires Bodycad Inc
027-207-100
In Commercial Distribution
- 00688346002065 ()
027-207-100
- Surgical screwdriver, reusable
No Description
Laboratoires Bodycad Inc
027-201-100
In Commercial Distribution
- 00688346001044 ()
027-201-100
- Surgical screwdriver, reusable
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
8ND1L
In Commercial Distribution
- 00860004002147 ()
- Suturing needle holder, reusable
No Description
FlexDex Surgical
8ND1M
In Commercial Distribution
- 00860004002130 ()
- Suturing needle holder, reusable
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
Screwdriver hexagon
Oticon Medical AB
M50534
In Commercial Distribution
- 05712149001026 ()
M50534
- Surgical screwdriver, reusable
Handle with screwdriver. Consists of handle (DM DI 05712149024568) and screwdriver machine bit (DM DI 05712149000562).
Oticon Medical AB
M50437
In Commercial Distribution
- 05712149000654 ()
- 05712149024568 ()
M50437
- Surgical screwdriver, reusable
Square fit connection, machine
Oticon Medical AB
M50386
In Commercial Distribution
- 05712149000586 ()
M50386
- Surgical screwdriver, reusable
Screwdriver, machine, 35mm
Oticon Medical AB
M50384
In Commercial Distribution
- 05712149000562 ()
M50384
- Surgical screwdriver, reusable
Nylon Facing For #1 Mallet
HU-FRIEDY MFG. CO., LLC
PTNFM1
Not in Commercial Distribution
- 10889950020668 ()
PTNFM1
- Surgical mallet
Insertion indicator
Oticon Medical AB
M52366
Not in Commercial Distribution
- 05712149009909 ()
M52366
- Surgical screwdriver, reusable
Abutment inserter, machine
Oticon Medical AB
M51695
In Commercial Distribution
- 05712149005895 ()
M51695
- Surgical screwdriver, reusable
Le Fort Surgical Guide - Wall with Splints - Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution
- 00860007543494 ()
GCLPFBC
- Custom-made orthopaedic/craniofacial surgical guide
Le Fort Surgical Guide - Slots with Splints - Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution
- 00860007543487 ()
GCLRFBC
- Custom-made orthopaedic/craniofacial surgical guide
Le Fort Surgical Guide - Wall Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution
- 00860007543470 ()
GCLPBC
- Custom-made orthopaedic/craniofacial surgical guide
Le Fort Surgical Guide - Slots Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution
- 00860007543463 ()
GCLRBC
- Custom-made orthopaedic/craniofacial surgical guide
Final Orthognathic Surgical Splint
Techfit Digital Surgery, Inc.
0
In Commercial Distribution
- 00860007543456 ()
FFCOBC
- Custom-made orthopaedic/craniofacial surgical guide
Intermediate Orhognathic Surgical Splint
Techfit Digital Surgery, Inc.
0
In Commercial Distribution
- 00860007543449 ()
FICOBC
- Custom-made orthopaedic/craniofacial surgical guide
2.0 - 3.2 Pin Driver Assembly
Insurgical, Inc.
320-0070-001
In Commercial Distribution
- 00860007230066 ()
9250022
- Pin-driving power tool attachment
3.2 - 4.0 Pin Driver Assembly
Insurgical, Inc.
320-0107-001
In Commercial Distribution
- 00860007230059 ()
9250023
- Pin-driving power tool attachment
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
ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM HYBRID GUIDES, SINGLE JAW
Medcad
MC-KTP010-H
In Commercial Distribution
- 00864582000298 ()
MC-KTP010-H
- Dental milling system, CAD/CAM, laboratory
- Custom-made organ/bone anatomy model/surgical guide kit
- Craniofacial fixation plate, non-bioabsorbable, non-customized
ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM GUIDES, SINGLE JAW
Medcad
MC-KTP010
In Commercial Distribution
- 00864582000281 ()
MC-KTP010
- Craniofacial fixation plate, non-bioabsorbable, non-customized
- Custom-made organ/bone anatomy model/surgical guide kit
- Dental milling system, CAD/CAM, laboratory
ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM HYBRID GUIDES
Medcad
MC-KTP000-H
In Commercial Distribution
- 00864582000274 ()
MC-KTP000-H
- Dental milling system, CAD/CAM, laboratory
- Custom-made organ/bone anatomy model/surgical guide kit
- Craniofacial fixation plate, non-bioabsorbable, non-customized
OsteoMed Manual Driver Handle
FHC, INC.
66-WP-DH-00323
In Commercial Distribution
- 00873263003237 ()
66-WP-DH
- Neurological stereotactic surgery system
WayPoint Combination Driver Bit with Collar
FHC, INC.
66-WP-CD-01-00320
In Commercial Distribution
- 00873263003206 ()
66-WP-CD-01
- Neurological stereotactic surgery system
WayPoint Combination Driver Bit
FHC, INC.
66-WP-CD-00318
In Commercial Distribution
- 00873263003183 ()
66-WP-CD
- Neurological stereotactic surgery system