FDA.reportPublic FDA data

BodyMed

Primary DI
20815802010126
Brand
BodyMed
Company
BOXOUT, LLC
Model
ZZHP1427
Catalog number
ZZHP1427
Device description
BodyMed heating pad, 14"x27", white cover
Published
2016-09-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

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
10815802010129PackageGS11In Commercial Distribution
20815802010126PackageGS110In Commercial Distribution
00815802010122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081580201012910815802010129
2081580201012620815802010126
00815802010122008158020101228158020101220815802010122

GMDN Terms#

Term, Definition table
TermDefinition
Electric pad whole-body heating system padAn electrically-heated underlay or overlay intended to provide heat under or over a patient as part of an electrical heating pad system used to heat a patient’s whole body (i.e., elevate core body temperature) typically in surgical and intensive care settings. The underlay/overlay typically contains electrical heating elements or cables supplied with energy by a dedicated control unit. The underlay/overlay is available in a variety of lengths, widths, and thicknesses to accommodate body size and application (e.g., adult/paediatric, full-/partial-body). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-528-2152info@bodysportproducts.com

Regulatory Flags#

DUNS number
066689993
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815991024405BodyMedBDMNEBCOM2022-07-01
00815991024412BodyMedBDMNEBDOG2022-07-01
00815991025167BodyMedBDMNEBCOMREU2025-07-17
00815991024047BodyMedBDMNTRGVMEDBDMNTRGVMED2024-12-04
00815991024054BodyMedBDMNTRGVSMBDMNTRGVSM2024-12-04
00815991024061BodyMedBDMNTRGVXLGBDMNTRGVXLG2024-12-04
00815991024078BodyMedBDMNTRGVXSBDMNTRGVXS2024-12-04
00815991024030BodyMedBDMNTRGVLRGBDMNTRGVLRG2024-12-04
20815991024041BodyMedBDMNTRGVMEDBDMNTRGVMED2024-12-04
20815991024058BodyMedBDMNTRGVSMBDMNTRGVSM2024-12-04
20815991024065BodyMedBDMNTRGVXLGBDMNTRGVXLG2024-12-04
20815991024072BodyMedBDMNTRGVXSBDMNTRGVXS2024-12-04
00815991025181BodyMedBDMPULSEOXBDMPULSEOX2024-10-11
20815991025185BodyMedBDMPULSEOXBDMPULSEOX2024-10-11
00815802010122BodyMedZZHP1427ZZHP14272016-09-05
00815802010139BodyMedZZHP1414ZZHP14142016-09-05
00815802010146BodyMedZZHP147ZZHP1472016-09-05
00815802010153BodyMedZZHP832UZZHP832U2016-09-05
00815802018715BodyMedZZHP1427BLKZZHP1427BLK2016-08-01
00815991022623BodyMedZZHPS1623ZZHPS16232019-10-18

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