HCLL

Primary DI
B105HCLL0
Brand
HCLL
Company
WELLSKY CORPORATION
Model
2015R2
Device description
HCLL 2015R2 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling.There is no hardware or other components included in the final product.HCLL 2015R2 is intended to address allphases of transfusion services activities, and assists transfusion service personnel: • Manipulate and label products • Print ISBT128 blood labels • Perform electronic cross match • Issue blood products under normal and emergency conditions • Receive andtest patient and unit specimens • Interface to blood bank testing instruments (bi-directional) • Interface to blood storage device (bidirectional)HCLL 2015R2 provides customized control processes for transfusion management of all procedures andtesting on products and patients to reduce human error and enhance the ability to assure patient and product safety.
Published
2023-06-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MMHBlood Establishment Computer Software And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMHBlood Establishment Computer Software And AccessoriesHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK1600660

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1600660

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B105HCLL0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Blood bank information system application softwareAn application software program, routines, and/or algorithms intended to be used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute administrative and clinical data within blood-bank centres. It accumulates data on blood-donor status and may include algorithms to process blood-bank information. It may perform additional tasks such as autologous and direct unit tracking, cross-match result determination, and/or management of bar-code information and patient history reports. It is typically supplied for installation into a blood bank information system, or mainframe or decentralized computers/networks.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
177240249
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B105TRANSFUSION20250WellSky Transfusion20252026-01-14
B10520241WellSky Blood Centers 20242024-05-31
B105TRANSFUSION20240WellSky Transfusion20242023-12-14
B105TRANSFUSION2023WellSky Transfusion20232023-12-06
B105BLOODCENTERS2018WellSky Blood Centers20182023-06-12
B105LIFETRAK0LifeTrak20122023-06-12
B105BLOODCENTERS2023WellSky Blood Centers20232023-05-12
B105BLOODCENTERS0WellSky Blood Centers20222022-02-10
B105TRANSFUSION0WellSky Transfusion20222022-02-10
B105TRANSFUSION2020WellSky Transfusion20202021-02-09
B105TRANSFUSION2021WellSky Transfusion20212021-02-09
B105BLOOD2020WellSky Blood - Emergency Issue20202020-06-15
B105TRANSFUSION20190WellSky Transfusion20192019-09-19
B105BLOODCENTERS2019WellSky Blood Centers20192019-05-09
B105TRANSFUSION20180WellSky Transfusion20182018-09-14

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