FDA.report

CVS FOREHEAD THERMOMETER

Primary DI
00050428313176
Brand
CVS FOREHEAD THERMOMETER
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
ACP # 91-50201
Device description
Forehead Thermometer
Published
2022-02-25
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

Related Records

Contact Domains

Product Codes

CodeName
KPDStrip, Temperature, Forehead, Liquid Crystal

Product Code Classifications

CodeDeviceSpecialtyClass
KPDStrip, Temperature, Forehead, Liquid CrystalGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00050428313176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00050428313176000504283131760504283131760050428313176

GMDN Terms

TermDefinition
Liquid-crystal patient thermometer, reusableA device designed to measure a patient's skin, oral, rectal, or axillary (armpit) body temperature. It uses liquid-crystal sensors (usually formed from esters of cholesterol) that are sealed in a plastic band and appear to change colour at indicated temperatures. The device may be used in the home. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature68 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-746-7287xx@xx.xx

Regulatory Flags

DUNS number
062312574
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
false
Sterilization required before use
false

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20815236021071TempTrend IILCR HALLCREST, LLC.KPD2022-06-20
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20815236020197Crystaline® Moving LineLCR HALLCREST, LLC.KPD2022-03-01
00815236020209Crystaline® Moving LineLCR HALLCREST, LLC.KPD2022-03-01
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10815236021043FeverScan Mini DisposableLCR HALLCREST, LLC.KPD2020-10-26
00815236020100Crystaline IILCR HALLCREST, LLC.KPD2020-10-26
00815236020322TempAlert IILCR HALLCREST, LLC.KPD2020-10-26
00029431000021ATI, Inc.AMERICAN THERMAL INSTRUMENTS, INC.KPD2020-09-30
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00029431000847ATI, Inc.AMERICAN THERMAL INSTRUMENTS, INC.KPD2020-08-11
00815236021022FeverScan UltraLCR HALLCREST, LLC.KPD2020-04-13
00815236021039FeverScan UltraLCR HALLCREST, LLC.KPD2020-04-13
00815236020988Summer InfantLCR HALLCREST, LLC.KPD2020-03-18
00815236021008Feverscan LargeLCR HALLCREST, LLC.KPD2019-01-15
00815236021015GuardianLCR HALLCREST, LLC.KPD2019-01-15
00817518021393Sharn IncSharn AnesthesiaKPD2018-10-10