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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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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
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 EmbryoSlide+ culture dish is a radiation-sterilized polystyrene culture dish containing two separate reservoirs. Each reservoir has eight culture wells, and each well is used to culture one embryo. Therefore, a total of 16 embryos can be cultured on one dish. Each dish includes four special wells that are only used for rinsing and handling the embryos either before or after incubation. An adhesive barcode label printed from the EmbryoViewer software is used to mark each dish. The barcode label contains two different 2D data matrices that provide information on the patient (name, patient ID, treatment ID, and insemination time). The EmbryoSlide+ culture dish has a sterility assurance level of 10-6 and a shelf-life of four years. This device is subject to mouse embryo assay (MEA) and endotoxin testing before lot release.
Vitrolife A/S
16450
In Commercial Distribution

  • 05712714664502 ()
  • 15712714664509 ()
16450

  • Assisted reproduction procedure dish
A native iOS and Android mobile application also compatible with iPad. It is used to: • Locate patients according to patient ID • Locate scheduled procedures by connecting to modality worklist • Capture videos, images and audio files to be included in the study case. • Add notes and tags to each file (asset). • Upload any file to the Orpheus System • Manually or automatically delete files from the file library
ORPHEUS MEDICAL LTD
01
In Commercial Distribution

  • 07290017025124 ()
ML-EG30001

  • Radiology information system application software
A native iOS and Android mobile application also compatible with iPad. It is used to: • Locate patients according to patient ID • Locate scheduled procedures by connecting to modality worklist • Capture videos, images and audio files to be included in the study case. • Add notes and tags to each file (asset). • Upload any file to the Orpheus System • Manually or automatically delete files from the file library
ORPHEUS MEDICAL LTD
01
In Commercial Distribution

  • 07290017025100 ()
MLL-EG30001

  • Radiology information system application software
AMSure® Pre-Connected Urethral Tray 14 Fr. Red Rubber Urethral Catheter Pre-Connected to Drainage Bag 1 each 1200 mL Drainage Bag with Pre-Connected 14 Fr. Red Rubber Urethral Catheter CONTENTS STERILIZED USING ETHYLENE OXIDE: 1 each CSR Wrap 1 each Waterproof Absorbent Underpad 1 pair Pre-Cuffed Nitrile Gloves 1 each Fenestrated Drape 1 pack Package Sterile Lubricating Jelly 1 each 2 oz Specimen Container with ID Label NON-STERILE CONTENT: 1 pack BZK Swabsticks (3)
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411007549 ()
  • 10704411007548 ()
AS89214K

  • Intermittent urethral catheterization kit
AMSure® Pre-Connected Urethral Tray 16 Fr. Red Rubber Urethral Catheter Pre-Connected to Drainage Bag CONTENTS STERILIZED USING ETHYLENE OXIDE: 1 each 1200 mL Drainage Bag with Pre-Connected 16 Fr. Red Rubber Urethral Catheter 1 each CSR Wrap 1 each Waterproof Absorbent Underpad 1 pair Pre-Cuffed Nitrile Gloves 1 each Fenestrated Drape 1 pack Package Sterile Lubricating Jelly 1 each 2 oz Specimen Container with ID Label NON-STERILE CONTENT: 1 pack BZK Swabsticks (3)
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411007532 ()
  • 10704411007531 ()
AS89216K

  • Intermittent urethral catheterization kit
MICRO VENTRICULAR BOLT PRESSURE-TEMPERATURE MONITORING KIT
NATUS MEDICAL INCORPORATED
110-4HMT
In Commercial Distribution


  • 4 Fr (1.35 mm diameter) transducer tipped catheter; 12 Fr ventricular access device with bolt
  • 0.209 in. (5.31 mm) diameter No. 4 Drill Bit with Safety Stop; Ventricular catheter having OD of 3.7 mm, ID of 2.2 mm, and adjustable length from 6 - 8 cm.;
1104HMT

  • Intracerebral sensor catheter, short-term
MICRO VENTRICULAR BOLT PRESSURE MONITORING KIT
NATUS MEDICAL INCORPORATED
110-4HM
In Commercial Distribution


  • 4 Fr (1.35 mm diameter) transducer tipped catheter; 12 Fr ventricular access device with bolt
  • 0.209 in. (5.3 mm) diameter No. 4 Drill Bit with Safety Stop; Ventricular catheter having OD of 3.7 mm, ID of 2.2 mm, and adjustable length from 6 - 8 cm.;
1104HM

  • Intracerebral sensor catheter, short-term
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