FDA.reportPublic FDA data

American Red Cross

Primary DI
B268Y78251
Brand
American Red Cross
Company
TOMY INTERNATIONAL, INC.
Model
Y7825
Catalog number
Y7825A1
Device description
ARC Ready For Baby Kit
Published
2019-11-04
Public version status
Update
Distribution status
Not 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
B268Y78251PackageHIBCC1In Commercial Distribution
B268Y78253PackageHIBCC3In Commercial Distribution
B268Y78259PackageHIBCC4In Commercial Distribution

GMDN Terms#

Term, Definition table
TermDefinition
Baby care kitA portable collection of devices and supplies designed to assist in the care of infants/babies. The collection typically includes a thermometer, medical measuring spoon/dropper, nasal aspirator, a teether, nail clippers, and grooming utensils (e.g., comb and brush). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
065183758
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B268L274120LAMAZE/JOHN DEEREL27412L274122019-09-23
B268Y7078A80The First YearsY7078A8Y7078A82025-09-22
B268Y7078A81The First YearsY7078A8Y7078A82025-09-22
B26879570The First YearsY7957Y79572024-01-18
B268L276190LamazeL27619L276192018-07-01
B268Y108960American Red CrossY10896Y108962017-11-13
B268Y5288L0LamazeY5228L2019-10-11
B268Y60530The First YearsY60532017-02-11
B268Y62280The First YearsY62282017-02-11
B268Y7054Y70570American Red CrossY7054, Y7057Y70572017-12-29
B268Y7054Y705701American Red CrossY7054Y70542017-12-20
B268Y70780American Red CrossY70782016-09-23
B268Y71490American Red CrossY71492017-05-29
B268Y77900American Red CrossY7790Y77902017-11-15
B268Y79160American Red CrossY7916Y79162022-03-31
B268Y52880The First YearsY52882017-02-11
B268Y7078A70The First YearsY7078A7Y7078A72024-03-25
B268Y7078A71The First YearsY7078A7Y7078A72024-03-25
B268Y79571The First YearsY7957Y79572024-01-18
B268Y7057A51The First YearsY7057A5Y7057A52024-01-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.FLL2026-06-03
00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.FLL2026-06-03
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
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048040WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
08698870325211FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22