FDA.reportPublic FDA data

Unimed

Primary DI
06945664899130
Brand
Unimed
Company
Unimed Medical Supplies, Inc.
Model
F503-254R
Device description
Disposable blood oxygen probe/adhesive foam /Masimo/RD Rainbow Set/adult /0.9M
Published
2021-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
06945664899130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945664899130069456648991306945664899130

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter probe, single-useA photoelectric device applied externally to a body site, e.g., a fingertip, ear lobe, the bridge of nose, a toe, or the bridge of the foot of a paediatric or adult patient for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using light detection. The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector, are received by an oximeter to which this device is connected. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., electrocardiogram (ECG). The is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
527971025
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06945664833790UnimedHPMA5-90DS2016-08-22
06945664833837UnimedMQM5-90DS2016-08-22
06945664833875UnimedLQ5-90DP02016-08-22
06945664833905UnimedHTM5-90DS2016-08-22
06945664833974UnimedMQM3-90DS2016-08-22
06945664834063UnimedLQ5-90DS02016-08-22
06945664834186UnimedATM5-90DS2016-08-22
06945664834193UnimedD3M-90DS2016-08-22
06945664834209UnimedHPM3-90DS2016-08-22
06945664834254UnimedLDT3-90DP02016-08-22
06945664834414UnimedLHT5-90DP02016-08-22
06945664834452UnimedHP5-90DPM2016-08-22
06945664834469UnimedLPA5-90DS02016-08-22
06945664834537UnimedLPA5-90DP02016-08-22
06945664834735UnimedL5-90DP02016-08-22
06945664835046UnimedMQM5-90DP2016-08-22
06945664835077UnimedLKB6-90DP02016-08-22
06945664835084UnimedL3-90DP02016-08-22
06945664835640UnimedLHT5-90DS02016-08-22
06945664835671UnimedHPA5-90DP2016-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09551028900069Cables and SensorsXINMED SDN. BHD.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
08052990320707MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2025-12-19
G096MNKS2NORAC30MEDALinkRising Eagle Medical LLCDQA2025-10-08
08052990321704MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2025-02-27
08052990320264MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2024-11-25
08052990320271MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2024-11-25
08052990322084MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2024-11-25
08052990322213MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2024-11-25
10197344042647MEDLINEMEDLINE INDUSTRIES, INC.DQA2024-09-27
10197344042678MEDLINEMEDLINE INDUSTRIES, INC.DQA2024-09-27
10197344042692MEDLINEMEDLINE INDUSTRIES, INC.DQA2024-09-27
10197344042715MEDLINEMEDLINE INDUSTRIES, INC.DQA2024-09-27
10197344042739MEDLINEMEDLINE INDUSTRIES, INC.DQA2024-09-27
07630002800754HAMILTON-T1Hamilton Medical AGDQA2024-08-21
10843997003343LNCSMASIMO CORPORATIONDQA2024-08-16
10843997003381LNCSMASIMO CORPORATIONDQA2024-08-16
10843997003398LNCSMASIMO CORPORATIONDQA2024-08-16
10843997003404LNCSMASIMO CORPORATIONDQA2024-08-16
10843997003411LNCSMASIMO CORPORATIONDQA2024-08-16
10843997010983RD SETMASIMO CORPORATIONDQA2024-08-16
10843997010990RD SETMASIMO CORPORATIONDQA2024-08-16
07640121880988103149 Calibration GasSenTec AGDQA2024-07-05
07640121880995103164 tCOM+SenTec AGDQA2024-07-05