FDA.reportPublic FDA data

CareWise

Primary DI
B939CW5APO1060
Brand
CareWise
Company
SOUTHERN SCIENTIFIC LIMITED
Model
CW4000
Catalog number
CW5APO106
Device description
C-Trak Apollo Analyser CW4000
Published
2023-01-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IZDProbe, Uptake, Nuclear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZDProbe, Uptake, NuclearRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B939CW5APO1060PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multichannel radiation counting systemA device assembly having multichannel analyser capabilities and designed to detect and quantify radiation emissions and differentially identify unknown radioactive isotopes. Typically a component of imaging or laboratory systems, it has the capability to be adjusted in a manner that allows the user to simultaneously count and differentiate emissions from multiple radioactive isotopes. It incorporates a spectrometer, permanently attached or interchangeable detectors, e.g., probes, a linear amplifier, an adjustable pulse height selector, automated spectral analysis and processing capabilities, a printer, and a display (usually a scalar or count rate meter).

Contacts#

Phone, Email table
PhoneEmail
+441273497600info@southernscientific.co.uk

Regulatory Flags#

DUNS number
289858417
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B939CW5APO1050CareWiseApollo Wireless Handset AccessoryCW5APO1052023-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841911103615NeoprobeDEVICOR MEDICAL PRODUCTS, INC.IZD2025-07-28
00841911103622NeoprobeDEVICOR MEDICAL PRODUCTS, INC.IZD2025-07-28
B619K0018C01UP0GammaPro Straight Standard ProbeKubtecIZD2025-03-26
B619K0019C01UW0GammaPro High Sensitivity ProbeKubtecIZD2025-03-26
B619K0020C01TA0GammaPro Laparoscopic ProbeKubtecIZD2025-03-26
B619K0021C01TH0GammaPro Angled Standard ProbeKubtecIZD2025-03-26
00841911102526neoprobeDEVICOR MEDICAL PRODUCTS, INC.IZD2024-09-16
00841911102533neoprobeDEVICOR MEDICAL PRODUCTS, INC.IZD2024-09-16
00841911102540neoprobeDEVICOR MEDICAL PRODUCTS, INC.IZD2024-09-16
00841911102557neoprobeDEVICOR MEDICAL PRODUCTS, INC.IZD2024-07-31
04260152884415Navigator 3 Wired Probe, 13mm Straightcrystal-photonics GmbHIZD2024-03-19
04260152884422Navigator 3 Wired Probe Cablecrystal-photonics GmbHIZD2024-03-19
04260152884484Navigator 3 Wired Probe, 14 mm Angledcrystal-photonics GmbHIZD2024-03-19
04260152884491Navigator 3 WirelessPprobe, 13mm Straightcrystal-photonics GmbHIZD2024-03-19
04260152884507Navigator 3 Wireless Probe, 14 mm Angledcrystal-photonics GmbHIZD2024-03-19
04260152884514Navigator 3 Wireless Probe Battery Packcrystal-photonics GmbHIZD2024-03-19
04260152887102Navigator 3 Control Unitcrystal-photonics GmbHIZD2024-03-19
00860008268907Node Seeker 2000INTRA MEDICAL IMAGING LLCIZD2023-05-03
08437018413294GAMMAPROGENERAL EQUIPMENT FOR MEDICAL IMAGING SAIZD2023-01-18
B939CW5APO1050CareWiseSOUTHERN SCIENTIFIC LIMITEDIZD2023-01-16
00850014578008Lara ReaderLUCERNO DYNAMICS, LLCIZD2023-01-01
00850014578015Lara Sensor, Type 1LUCERNO DYNAMICS, LLCIZD2023-01-01
00850014578022Lara Sensor, Type 2LUCERNO DYNAMICS, LLCIZD2023-01-01
00850014578039Lara Sensor, Type 3LUCERNO DYNAMICS, LLCIZD2023-01-01
00850014578046Lara Sensor, Type 4LUCERNO DYNAMICS, LLCIZD2023-01-01
00850014578053Lara Sensor, Type 5LUCERNO DYNAMICS, LLCIZD2023-01-01
00850014578060Lara Sensor, Type 6LUCERNO DYNAMICS, LLCIZD2023-01-01
00850014578077Lara Sensor, Type 7LUCERNO DYNAMICS, LLCIZD2023-01-01
00850014578084Lara Sensor, Type 8LUCERNO DYNAMICS, LLCIZD2023-01-01
00850014578091Lara QC FixtureLUCERNO DYNAMICS, LLCIZD2023-01-01