FDA.reportPublic FDA data

ULTRA Laboratory Information System

Primary DI
05060508820024
Brand
ULTRA Laboratory Information System
Company
CIRDAN IMAGING LIMITED
Model
4.7, 4.8, 4.9
Device description
Digital image, storage and communication, non-diagnostic, laboratory information system
Published
2019-10-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
NVVDigital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NVVDigital Image, Storage And Communications, Non-Diagnostic, Laboratory Information SystemClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060508820024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060508820024050605088200245060508820024

GMDN Terms#

Term, Definition table
TermDefinition
Clinical laboratory information system application softwareAn application software program, routines, and/or algorithms used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with clinical laboratory services and facilities. It is typically supplied for installation into a dedicated information system used in the clinical laboratory or existing mainframe or decentralized computers/networks.

Contacts#

Phone, Email table
PhoneEmail
+442892660880info@cirdan.com

Regulatory Flags#

DUNS number
216744109
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060508820031ULTRA Transfusion Medicine4.7, 4.8, 4.92019-10-08
05060508820062Solas OR12026-05-05
05060508820017CoreLite12020-03-31
05060508820000Pathnet Blood Bank Transfusion (L-2300)4.12016-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B236CPP8030Clinisys CoPathPlusCliniSys, IncNVV2026-02-18
00860009458109SentinelVistapath Biosystems, Inc.NVV2023-05-01
B236VUE202210Sunquest VUECliniSys, IncNVV2022-12-19
04049016135210EUROLabOffice 4.0EUROIMMUN Medizinische Labordiagnostika AGNVV2022-12-08
B433CL0CyberLABASPYRA, LLCNVV2022-10-12
B236PWP13000Sunquest PowerPathCliniSys, IncNVV2022-04-14
B236CPP8000Sunquest CoPathPlusCliniSys, IncNVV2022-03-28
00859474006663SoftMediaSCC SOFT COMPUTERNVV2020-12-09
00859474006472SoftMediaSCC SOFT COMPUTERNVV2020-12-04
B236CPP7100Sunquest CoPathPlusCliniSys, IncNVV2020-11-12
B236PWP12000Sunquest PowerPathCliniSys, IncNVV2020-11-12
00859474006465SoftMediaSCC SOFT COMPUTERNVV2020-04-29
00859474006410SoftMediaSCC SOFT COMPUTERNVV2020-01-25
00859474006403SoftMediaSCC SOFT COMPUTERNVV2019-11-12
00859474006373SoftMediaSCC SOFT COMPUTERNVV2019-11-08
08800019600121Imaging System HIS-5000UHuvitz Co., Ltd.NVV2019-05-10
00859474006366SoftMediaSCC SOFT COMPUTERNVV2019-03-15
00859474006342SoftMediaSCC SOFT COMPUTERNVV2018-12-08
00859474006298SoftMediaSCC SOFT COMPUTERNVV2018-07-21
00859474006250SoftMediaSCC SOFT COMPUTERNVV2018-04-04
00859474006212SoftMediaSCC SOFT COMPUTERNVV2018-01-19
00859474006182SoftMediaSCC SOFT COMPUTERNVV2017-10-26
00859474006144SoftMediaSCC SOFT COMPUTERNVV2017-07-15
00859474006106SoftMediaSCC SOFT COMPUTERNVV2017-05-13