FDA.reportPublic FDA data

McKesson

Primary DI
40612479227758
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
16-413RGM
Device description
Digital Thermometers RECTAL 20 SECOND READING | WITH 5 PROBE SHEATHS
Published
2018-07-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40612479227758PackageGS112In Commercial Distribution
20612479227747PrimaryGS10
10612479227733Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4061247922775840612479227758
2061247922774720612479227747
1061247922773310612479227733

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent electronic patient thermometerA hand-held, battery-powered, electronic instrument designed to measure a patient's body temperature. It may comprise an electronic unit with an attached probe or be a single unit (shaped like an ordinary hand-held capillary thermometer) that detects and converts the changes in temperature into variations of some electrical characteristic, e.g., resistance or voltage. These variations of the electrical characteristics are processed in the electronic circuits and in turn displayed, for a short period, as temperature readings. Thereafter the display will automatically turn off or go into standby mode. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023904428
Device count
12
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
08698870325211FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22
08698870325297FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22
08698870325310FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22
08698870325389FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22
08698870335265FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22
08698870357830FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22
08698870368867FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22
08698870368874FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22
08698870371577FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22
08698870372604FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22
08698870376251FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22
08698870377968FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22
10192253068986CARDINAL HEALTHCardinal Health 200, LLCFLL2025-08-29
10192253068993CARDINAL HEALTHCardinal Health 200, LLCFLL2025-08-29
10192253069006CARDINAL HEALTHCardinal Health 200, LLCFLL2025-08-29
10192253069013CARDINAL HEALTHCardinal Health 200, LLCFLL2025-08-29
10192253069020CARDINAL HEALTHCardinal Health 200, LLCFLL2025-08-29
10192253069037CARDINAL HEALTHCardinal Health 200, LLCFLL2025-08-29
10192253069044CARDINAL HEALTHCardinal Health 200, LLCFLL2025-08-29
10192253069051CARDINAL HEALTHCardinal Health 200, LLCFLL2025-08-29
10192253069068CARDINAL HEALTHCardinal Health 200, LLCFLL2025-08-29
10192253069075CARDINAL HEALTHCardinal Health 200, LLCFLL2025-08-29
10192253069082CARDINAL HEALTHCardinal Health 200, LLCFLL2025-08-29
10192253069099CARDINAL HEALTHCardinal Health 200, LLCFLL2025-08-29
08720256776529Corsano CardioWatch 287-2 SystemCorsano Health B.V.FLL2024-06-19
08800065226726THERMOQUICK; THERMOCLICK; THERMOCARET&R BIOFAB CO.,LTDFLL2024-01-16
10884392950498Safety 1stDOREL JUVENILE GROUP, INC.FLL2023-06-15
10834098000904Disposable CapsEXERGEN CORPORATIONFLL2023-06-13
10884521828384Mon-a-ThermCovidien LPFLL2023-05-29
10884521828391Mon-a-ThermCovidien LPFLL2023-05-29