FDA.reportPublic FDA data

Rexall

Primary DI
00845717773300
Brand
Rexall
Company
DOLGENCORP, LLC
Model
77-330
Catalog number
77-330
Device description
Rexall Temple Touch Thermometer
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032362000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032362000UP-GRADE FOREHEAD THERMOMETERMedisim, Ltd.2003-12-04FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10845717773307PackageGS136In Commercial Distribution
30845717773301PackageGS12In Commercial Distribution
00845717773300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084571777330710845717773307
3084571777330130845717773301
00845717773300008457177733008457177733000845717773300

GMDN Terms#

Term, Definition table
TermDefinition
Infrared patient thermometer, skinA hand-held, electrically-powered instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
1-888-309-9030xx@xx.xx

Regulatory Flags#

DUNS number
068331990
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00017276224771Rexall0172762247712020-09-07
00834533001414DG HealthBDGGC362026-03-23
00834533001445DG HealthBDGGS182026-03-23
10834533001411DG HealthBDGGC362026-03-23
10834533001442DG HealthBDGGS182026-03-23
00751774000030DG Health20002256N/A2026-02-20
10751774000037DG Health20002256N/A2026-02-20
00751774242461Rexall One Step Pregnancy Test2020-07-10
00751774250473Rexall One Step Pregnancy Test2020-07-10
00197344018737RexallDG4335DG43352025-10-02
00751774260472Dollar GeneralOne Step Pregnancy Test2025-05-09
00751774262469DG HealthOne Step Pregnancy TestN/A2025-05-09
00845717090001Rexall77-35277-3522016-09-24
00845717773591Rexall77-35977-3592016-09-24
10751774260479Dollar GeneralOne Step Pregnancy Test2025-05-09
10751774262466DG HealthOne Step Pregnancy TestN/A2025-05-09
00646011887409Rexall Sterile Saline Wound Wash88-50740-200-002024-10-04
00197344110059RexallDG4345DG43452024-08-08
10197344110056RexallDG4345DG43452024-08-08
00751774250787DG healthOne Step Pregnancy TestN/A2023-10-27

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.FLL2026-06-02
06926347900459joybabeShenzhen Brav Electronic Technologies Co., Ltd.FLL2026-06-01
06942284618073One Step®JOYTECH HEALTHCARE CO.,LTDFLL2026-05-29
00884392020613Safety 1stDOREL JUVENILE GROUP, INC.FLL2026-05-28
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
08698870325211FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22