FDA.reportPublic FDA data

BluSat

Primary DI
30859998006416
Brand
BluSat
Company
OSI OPTOELECTRONICS, INC.
Model
1295
Device description
Adhesive Sensor Wrap, Universal
Published
2021-02-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30859998006416PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3085999800641630859998006416

GMDN Terms#

Term, Definition table
TermDefinition
Sensor holder, single-useA device designed to hold (house) a sensor so that it is fixed (locked) in a stable position, including adhesive fixation. It will then allow for the holder and the attached sensor to be fastened to, e.g., the patient's body, another device, or a suitable place in the vicinity of use. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
612770974
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859998006439TruLink015-0660-0021-008162021-02-24
00859998006446TruLink015-0661-0021-008172021-02-24
00859998006453TruLink015-0667-0021-008092021-02-24
00859998006460TruLink015-0666-0021-008102021-02-24
00859998006477TruLink015-0664-0021-008112021-02-24
00859998006484TruLink015-0665-0021-008122021-02-24
00859998006491TruLink015-0662-0021-008132021-02-24
00859998006507TruLink015-0663-0021-08142021-02-24
00859998006347BluSat42412021-02-02
00859998006354BluSat12932021-02-02
00859998006378BluSat40422021-02-02
10859998006306BluSat43412021-02-02
10859998006313BluSat43422021-02-02
10859998006320BluSat43432021-02-02
10859998006337BluSat43442021-02-02
30859998006300BluSat43412021-02-02
30859998006317BluSat43422021-02-02
30859998006324BluSat43432021-02-02
30859998006331BluSat43442021-02-02
00859998006361BluSat40412020-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048040WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
09551028900069Cables and SensorsXINMED SDN. BHD.DQA2026-04-22
06924054300586BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-04-22
08052990320318MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03
08052990320325MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03
08052990320387MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03
08052990320479MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03
08052990320561MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03
08052990320585MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03
08052990320691MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2025-12-19