FDA.reportPublic FDA data

PLAYHOUSE MD

Primary DI
00860013187774
Brand
PLAYHOUSE MD
Company
PLAYHOUSE METHOD INC.
Model
1051-R
Device description
Playhouse MD Fever buddy 3-in-1 Infrared Thermometer (Giraffe)
Published
2025-12-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
SDVClinical Electronic Thermometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SDVClinical Electronic ThermometerGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20860013187778PackageGS112In Commercial Distribution
00860013187774PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2086001318777820860013187778
00860013187774008600131877748600131877740860013187774

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.

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
20860013187778PLAYHOUSE MD1051-R2025-12-17
00860013187705PLAYHOUSE MD10512025-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00845717012188TrackstarVERIDIAN HEALTHCARE LLCSDV2026-09-04
00311917086569WalgreensWALGREEN CO.SDV2026-08-21
00311917086590WalgreensWALGREEN CO.SDV2026-08-21
00810110303812NuvomedNUVOMED, INC.SDV2026-08-19
00810110305014NuvomedNUVOMED, INC.SDV2026-08-19
06933257923157YUWELL® Infrared ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-08-19
06933257952744YUWELL® Infrared ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-08-19
06933257952751YUWELL® Infrared ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-08-19
06942284618080JOYTECHJOYTECH HEALTHCARE CO.,LTDSDV2026-08-14
10197344219575MEDLINEMEDLINE INDUSTRIES, INC.SDV2026-07-24
00860015688927HomedicsFKA DISTRIBUTING CO., LLCSDV2026-05-31
06933257929432YUWELL® Infrared Ear ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-05-07
06933257930711YUWELL® Infrared Ear ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-05-07
06933257931213YUWELL® Infrared Ear ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-05-07
06933257931244YUWELL® Infrared Ear ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-05-07
06933257931251YUWELL® Infrared Ear ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-05-07
06933257931268YUWELL® Infrared Ear ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-05-07
10840330706558ProCureTwin Med, LLCSDV2026-05-05
10840330706565ProCureTwin Med, LLCSDV2026-05-05
00860015673107Inito InTemp Basal ThermometerInito Health, Inc.SDV2026-04-08
04719003406516MicrolifeMICROLIFE USA, INC.SDV2026-01-31
04719883871350Fore HealthFORTECHGRP CO., LTD.SDV2026-01-28
04719883871374Fore HealthFORTECHGRP CO., LTD.SDV2026-01-28
04719883871381Fore HealthFORTECHGRP CO., LTD.SDV2026-01-28
04719883871435Fore HealthFORTECHGRP CO., LTD.SDV2026-01-28
04719883870070ForeHealthFORTECHGRP CO., LTD.SDV2026-01-26
00194346614042EquateWAL-MART STORES, INC.SDV2026-01-21
00850044118694iHealthiHealth Labs Inc.SDV2025-12-19
00850044118700iHealthiHealth Labs Inc.SDV2025-12-19
00850044118724iHealthiHealth Labs Inc.SDV2025-12-19