FDA.reportPublic FDA data

McKeeson

Primary DI
20612479107698
Brand
McKeeson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
18-D50
Device description
SHEATH, THERMOMETER ORAL DIGIT
Published
2016-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

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
40612479107708PackageGS1100In Commercial Distribution
20612479107698PrimaryGS10
10612479219820Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4061247910770840612479107708
2061247910769820612479107698
1061247921982010612479219820

GMDN Terms#

Term, Definition table
TermDefinition
Electronic thermometer probe coverA device intended to be used as a physical barrier between the patient and the probe of a thermometer that uses electronics to create the measurement, e.g., a tympanic (in-the-ear) or electronic (body) thermometer, to prevent cross-contamination between patients. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023904428
Device count
50
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
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
06970289030118hetaidaHetaida Technology Co., LtdFLL2026-05-24
06970289035120hetaidaHetaida Technology Co., LtdFLL2026-05-24
06970289035137hetaidaHetaida Technology Co., LtdFLL2026-05-23
06970289035144hetaidaHetaida Technology Co., LtdFLL2026-05-23
06953205995043Infrared ThermometerShenzhen Jiacom Technology Co., LtdFLL2026-03-20
00850022483370Dr. Noze Best ThermometerDr. Noze Best, LLCFLL2026-03-17
00851203006449TempTraq®BLUE SPARK TECHNOLOGIES, INC.FLL2026-02-26
00851203006470TempTraq®BLUE SPARK TECHNOLOGIES, INC.FLL2026-02-26
00851203006487TempTraq®BLUE SPARK TECHNOLOGIES, INC.FLL2026-02-26
00628693098144ByFloProductsByFlo LLCFLL2026-02-18
16972040113723TizziorShenzhen AOJ Medical Technology Co., LtdFLL2026-02-05
16972040113730TizziorShenzhen AOJ Medical Technology Co., LtdFLL2026-02-05
20328785004674VicksKAZ USA, INC.FLL2026-02-04
00328785004908BraunKAZ USA, INC.FLL2026-02-04
00328785005301VicksKAZ USA, INC.FLL2026-02-04
00328785006285VicksKAZ USA, INC.FLL2026-02-04
40328785013984BRAUNKAZ USA, INC.FLL2026-02-04
10328785007975BraunKAZ USA, INC.FLL2026-02-03
00328785008272BraunKAZ USA, INC.FLL2026-02-03
00328785012989BRAUNKAZ USA, INC.FLL2026-02-03
10328785014744BRAUNKAZ USA, INC.FLL2026-02-03
10328785006350VicksKAZ USA, INC.FLL2026-01-28
00328785012798BRAUNKAZ USA, INC.FLL2026-01-28
00328785014655BRAUNKAZ USA, INC.FLL2026-01-28
00328785014662BRAUNKAZ USA, INC.FLL2026-01-27
00328785014716BRAUNKAZ USA, INC.FLL2026-01-27
10311917052264WalgreensWALGREEN CO.FLL2025-12-31
06971567043066E+RWenzhou Yosun Medical Technology Co., Ltd.FLL2025-12-29
10850044118691iHealthIHEALTH LAB INC.FLL2025-12-19
10850044118707iHealthIHEALTH LAB INC.FLL2025-12-19