FDA.reportPublic FDA data

Safety 1st

Primary DI
00884392490584
Brand
Safety 1st
Company
DOREL JUVENILE GROUP, INC.
Model
49551
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00884392490584PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884392490584008843924905848843924905840884392490584

GMDN Terms#

Term, Definition table
TermDefinition
Infrared patient thermometer, earA hand-held, battery-powered, electronic instrument designed to measure the temperature of a patient's ear canal. In most cases it is intended to estimate the internal (core) temperature of the body by measurement of infrared radiation from within the auditory canal. It may claim to measure directly the infrared emissions from the tympanic membrane. An infrared ear thermometer usually displays values corrected by an offset of actual patient oral/rectal temperatures. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118841501
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884392008420Safety 1stIH4262025-12-15
10884392008427Safety 1stIH4262025-12-15
00884392004392Safety 1stIH6562024-12-15
00884392626020Safety 1stTH1042018-12-04
00884392949471Safety 1stIH5042023-11-15
20884392949475Safety 1stIH5042023-11-15
00884392950491Safety 1stIH5742023-06-15
10884392950498Safety 1stIH5752023-06-15
20884392950495Safety 1stIH5762023-06-15
30884392951079Safety 1stIH5942022-07-15
40884392951076Safety 1stIH5942022-07-15
00884392951078Safety 1stIH5942022-04-01
10884392951075Safety 1stIH5942022-04-01
20884392951072Safety 1stIH5952022-04-01
00884392625023Safety 1stIH4742018-11-29
00884392954451Safety 1stIH6012023-10-15
20884392954455Safety 1stIH6012023-10-15
10884392951822Safety 1stTH1112023-01-01
20884392951829Safety 1stTH1112023-01-01
00884392951825Safety 1stTH1112023-01-01

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