FDA.reportPublic FDA data

Temperature Probe

Primary DI
06944413804692
Brand
Temperature Probe
Company
Edan Instruments, Inc.
Model
skin，neonatal/Infant, 3m, reusable
Published
2016-09-01
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
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06944413804692PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06944413804692069444138046926944413804692

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose patient temperature probe, reusableA temperature sensing device intended to be placed into a body orifice or on the body surface and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529173163
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
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
06944413837164Diagnostic Ultrasound SystemNano L12 EXP2026-03-09
06944413837188Diagnostic Ultrasound SystemNano L122026-03-09
06944413837171Diagnostic Ultrasound SystemNano C52026-03-09
06944413836532Diagnostic Ultrasound SystemNano C5 EXP2026-03-09
06944413849570Holter ECG and ABP SystemHolterABP2026-03-02
06944413858664TOCO-MECG transducerTOCO-EF2026-02-06
06944413858671TOCO-MECG transducerTOCO-EA2026-02-06
06944413814714Trolley(For medical use)MT-5032025-12-09
06944413819726Trolley(For medical use)MT-8032025-12-09
06944413819733Trolley(For medical use)MT-8112025-12-09
06944413807112Remote Event Marker02.01.2100952025-11-29
06944413804197ECG Cable3-lead, 12-pin, Defib-proof, IEC, Snap2025-09-13
06944413815704ECG Cable6-lead, 12-pin, Defib-proof, Adult/pediatric2025-09-13
06944413815711ECG Cable6-lead, Clip, AHA, Adult/pediatric2025-09-13
06944413815728ECG Cable6-lead, Snap, AHA, Adult/pediatric2025-09-13
06944413815735ECG Cable6-lead, Clip, IEC, Adult/pediatric2025-09-13
06944413815742ECG Cable6-lead, Snap, IEC, Adult/pediatric2025-09-13
06944413838963C.O. AccessoriesConnection cable2025-09-14
06944413838406Patient Monitor CX102025-09-05
06944413838413Patient MonitorCX122025-09-05

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