FDA.reportPublic FDA data

PLAYHOUSE MD

Primary DI
00860013187705
Brand
PLAYHOUSE MD
Company
PLAYHOUSE METHOD INC.
Model
1051
Device description
Playhouse MD Fever buddy 3-in-1 Infrared Thermometer (Giraffe)
Published
2025-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
FLLContinuous Measurement Thermometer
SDVClinical Electronic Thermometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2
SDVClinical Electronic ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191570000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191570000Infrared Thermometer Model MD-H30Guangzhou Berrcom Medical Device Co., Ltd.2019-11-13FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860013187702PackageGS112In Commercial Distribution
00860013187705PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086001318770210860013187702
00860013187705008600131877058600131877050860013187705

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
138341064
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860013187774PLAYHOUSE MD1051-R2025-12-17
20860013187778PLAYHOUSE MD1051-R2025-12-17

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Primary DI, Brand, Company table
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00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
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