FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
20192253069096
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
16811ECOR
Catalog number
16811ECOR
Device description
Digital Rectal Thermometer, Fahrenheit
Published
2025-08-29
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
FLLContinuous Measurement Thermometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30192253069093Direct MarkingGS10
20192253069096PackageGS11In Commercial Distribution
50192253069097PackageGS120In Commercial Distribution
10192253069099PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3019225306909330192253069093
2019225306909620192253069096
5019225306909750192253069097
1019225306909910192253069099

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
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
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

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