FDA.reportPublic FDA data

McKesson

Primary DI
40612479244304
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
16-FTP
Device description
Basic Pulse Oximeter
Published
2019-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
40612479244304PackageGS16In Commercial Distribution
10612479244297PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4061247924430440612479244304
1061247924429710612479244297

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeterAn electrically-powered photoelectric device designed for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals are produced by light-emitting diodes (LEDs) and received by a photodetector. The device displays the SpO2 values and may also measure/display pulse rate. It is typically applied to the fingertip or around the wrist, may be single-component (with built-in probe) or multi-component (includes external probe), and may in addition wirelessly transmit measurements to a receiving location (e.g., central station, bedside monitor); it is intended to be operated by laypersons and healthcare providers.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023904428
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20612479282852McKessonM-1669H2026-05-26
20612479282883McKessonM-662G2026-05-26
20612479282890McKessonM-1667G2026-05-26
20612479282906McKessonM-1667H2026-05-26
20612479282913McKessonM-698G2026-05-26
20612479282920McKessonM-1666G2026-05-26
20612479282937McKessonM-1698G2026-05-26
20612479282944McKessonM-663G2026-05-26
20612479283019McKessonM-699G2026-05-26
20612479283194McKessonM-8699G2026-05-26
20612479283200McKessonM-8682G2026-05-26
20612479283217McKessonM-8698G2026-05-26
20612479283224McKessonM-8686G2026-05-26
20612479283231McKessonM-8697G2026-05-26
20612479283248McKessonM-8695G2026-05-26
20612479283255McKessonM-685G2026-05-26
20612479283385McKessonM-J494G2026-05-26
20612479283392McKessonM-J496G2026-05-26
20612479283408McKessonM-J493G2026-05-26
20612479283415McKessonM-J546G2026-05-26

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