FDA.reportPublic FDA data

American Red Cross

Primary DI
B268Y7054Y70570
Brand
American Red Cross
Company
TOMY INTERNATIONAL, INC.
Model
Y7054, Y7057
Catalog number
Y7057
Device description
Y7057 American Red Cross Healthcare & Grooming Kit (with Thermometer)
Published
2017-12-29
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
B268Y7054Y70571PackageHIBCC1Not in Commercial Distribution
B268Y7054Y70573PackageHIBCC3Not in Commercial Distribution
B268Y7054Y70579PackageHIBCC12Not in Commercial Distribution
B268Y7054Y70570PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Infant care kitA portable collection of devices and supplies designed to assist in the care of an infant/baby that typically includes two or more of the following: a thermometer, medical measuring spoon/dropper, nasal aspirator, irrigation saline solution, a teether, and nail clippers. This is a reusable device.

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
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
B268Y78251American Red CrossY7825Y7825A12019-11-04
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

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Primary DI, Brand, Company table
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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
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08698870325211FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22