FDA.reportPublic FDA data

CHATTANOOGA

Primary DI
00190446715962
Brand
CHATTANOOGA
Company
DJO, LLC
Model
1031-B
Device description
THERATHERM MOIST HEAT 14X14MED
Published
2022-05-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
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
00190446715962PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446715962001904467159621904467159620190446715962

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

Regulatory Flags#

DUNS number
081840873
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
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
00190446968344DJO SURGICALS-2019632026-03-16
00190446953685DJO SURGICALS-2019592026-02-17
00190446953708DJO SURGICALS-2019582026-02-17
00888912408691DJO SURGICAL800-05-0242023-01-18
00190446940920DJO SURGICALS-2019462025-11-18
00190446660453PROCARE155-81-974272025-07-23
00190446660576PROCARE155-81-971502025-07-23
00190446662686PROCARE155-BH-1942025-07-23
00190446660354PROCARE155-79-843002025-07-14
00190446660583PROCARE155-79-84100C2025-07-14
00190446662785PROCARE155-BH827102025-07-14
00190446662891PROCARE155-81-874802025-07-14
00190446662907PROCARE155-81-874902025-07-14
00190446662914PROCARE155-81-874602025-07-14
00190446662921PROCARE155-81-874702025-07-14
00190446662792PROCARE155-81-873022025-07-11
00190446662808PROCARE155-81-873032025-07-11
00190446662815PROCARE155-81-873052025-07-11
00190446662822PROCARE155-81-873072025-07-11
00190446662839PROCARE155-81-873082025-07-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00024291256076HANDY SOLUTIONS HEATING PAD WRAP SHOULDER AND NECKNavajo Manufacturing CompanyIRT2026-01-29
00087453001662HygenicHYGENIC CORPORATION, THEIRT2026-01-13
00087453001679HygenicHYGENIC CORPORATION, THEIRT2026-01-13
10041298995040DMID-M-S HOLDINGS, INC.IRT2025-12-30
06950940802827N/AShenzhen Osto Technology Co.,Ltd.IRT2025-12-20
00053891181952SunbeamJarden Consumer SolutionsIRT2025-12-03
10810140062298iDOO Heating PadJoicom CorporationIRT2025-08-29
00846841092596mibestBeijing Choice Electronic Technology Co., Ltd.IRT2025-07-23
00860163001517BIOMAT QUEENRICHWAY & FUJI BIO INC.IRT2025-06-16
00860163001524BIOMAT PROFESSIONALRICHWAY & FUJI BIO INC.IRT2025-06-16
00860163001531BIOMAT SINGLERICHWAY & FUJI BIO INC.IRT2025-06-16
00860163001548BIOMAT MINIRICHWAY & FUJI BIO INC.IRT2025-06-16
00860163001555BIO-BELTRICHWAY & FUJI BIO INC.IRT2025-06-16
10041298991967DMID-M-S HOLDINGS, INC.IRT2025-06-12
00199284161986Berkshire Blanket & Home Co. Inc.Berkshire Blanket & Home Co., Inc.IRT2025-06-01
00199284703056Berkshire Blanket & Home Co. Inc.Berkshire Blanket & Home Co., Inc.IRT2025-06-01
00199284943056Berkshire Blanket & Home Co. Inc.Berkshire Blanket & Home Co., Inc.IRT2025-06-01
00311917052458WalgreensWALGREEN CO.IRT2025-05-30
088095244965333H3H, Co., LtdIRT2025-05-30
088095244965953H3H, Co., LtdIRT2025-05-30
088095244966703H3H, Co., LtdIRT2025-05-30
00810140062147RENPHO Heating PadJoicom CorporationIRT2025-05-29
00810140062154RENPHO Heating PadJoicom CorporationIRT2025-05-29
00810140062161RENPHO Heating PadJoicom CorporationIRT2025-05-29
00810140062178RENPHO Heating PadJoicom CorporationIRT2025-05-29
00810140062192iDOO Heating PadJoicom CorporationIRT2025-05-29
00810140062208iDOO Heating PadJoicom CorporationIRT2025-05-29
00810140062215iDOO Heating PadJoicom CorporationIRT2025-05-29
00810140062222iDOO Heating PadJoicom CorporationIRT2025-05-29
00810140062246RENPHO Heating PadJoicom CorporationIRT2025-05-29