FDA.reportPublic FDA data

Mibest

Primary DI
00846841019005
Brand
Mibest
Company
Beijing Choice Electronic Technology Co., Ltd.
Model
CHP1B2
Device description
Heating Pad
Published
2018-10-25
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
IRTPad, Heating, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRTPad, Heating, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846841019005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846841019005008468410190058468410190050846841019005

GMDN Terms#

Term, Definition table
TermDefinition
Reactive-gel heating padAn underlay intended to produce heat through chemical reaction typically used to warm and/or maintain the body temperature of neonates or infants. It is typically designed with a soft outer casing (e.g., a soft plastic) that contains a chemically-reactive gel activated by the user (e.g., by breaking its inner enclosure) to provide a heat of approximately normal body temperature (e.g., 38? Celsius) for a limited period. This device is typically used to maintain the body temperature of infant patients during transportation and may be x-ray translucent and magnetic resonance imaging (MRI) compatible. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
526882823
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06942820462535BLUE JAYBJ2401052026-01-23
00846841010262mibestCHP1C12021-09-24
00846841010279mibestCHP1C1-Gel2021-09-24
06942820462511VIEW O2180-50572025-12-23
06942820462528OxywatchDSI-DSFP-22025-12-23
00846841092527ChoiceMMedOxyWatch C292025-09-29
00846841092695ChoiceMMedMD300CN568R2025-09-24
00846841060830Henry Schein112-70632016-09-29
00846841060724ChoiceMMedMDN1042018-05-29
00846841060762ChoiceMMedMDN1052016-09-28
00846841092596mibestIBH-0012025-07-23
00846841091599mibestMD300C572025-07-22
00846841092565ChoiceMMedMD300CI218R2025-07-22
00846841092701mibestMD300C562025-07-22
00846841092947ChoiceMMedOxyWatch C2052025-07-22
00846841092954ChoiceMMedMD300CN550R2025-07-22
06942820462504Choicemmed MD300W6282025-07-22
00846841092589mibestNA-0022025-07-18
06942820462368ChoicemmedMD300CI218R2025-04-27
06942820462375ChoicemmedMD300CI216R2025-04-27

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00622356710718Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356712200Shark™ DePuffi™SharkNinja Operating LLCIRT2026-06-02
00622356736633Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
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