FDA.reportPublic FDA data

40670 Hot Pink Pad Controller (Assembled)

Primary DI
00787551013047
Brand
40670 Hot Pink Pad Controller (Assembled)
Company
XODUS MEDICAL, INC.
Model
40670
Catalog number
40670
Device description
40670 Hot Pink Pad Controller (Assembled)
Published
2026-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWJSystem, thermal regulating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWJSystem, Thermal RegulatingCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K260903000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260903000Hot Pink Pad Warming SystemXodus Medical, Inc.2026-04-16DWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20787551013041PackageGS11In Commercial Distribution
00787551013047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2078755101304120787551013041
00787551013047007875510130477875510130470787551013047

GMDN Terms#

Term, Definition table
TermDefinition
Electric pad whole-body heating systemAn assembly of electrically-powered devices designed to heat a patient's whole body to compensate for the loss of normal body heat. The system includes a flat pad with electrical heating elements designed to be placed under or over the patient, and a control unit to regulate the heat; some types may be capable of monitoring the temperature at the patient’s body surface. The pad is available in a variety of lengths, widths, and thicknesses to accommodate body size and applications (e.g., adult/paediatric, full-/partial-body). It is typically used in the operating room (OR), adult or neonatal intensive care unit (ICU), recovery units, or during neonatal transportation.

Contacts#

Phone, Email table
PhoneEmail
+1(724)337-5500plloyd@xodusmedical.com

Regulatory Flags#

DUNS number
868042664
Device count
1
Lot or batch
true
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
0078755100057330500 Cautery Tip Cleaner30500305002017-05-01
0078755104140840671 Hot Pink Pad XL - with Arm Protectors40671406712026-04-30
00787551041415SPK11731 Jackson Table KitSPK11731SPK117312026-04-30
0078755104142240697 The Pink Pad XL - Advanced Trendelenburg Positioning Kit with Adult Head R40697406972026-04-30
00787551041439LPK10035 Lateral Positioning KitLPK10035LPK100352026-04-30
00787551041446CL25313 Custom Med Label PackCL25313CL253132026-04-30
0078755104153840440 Trendelenburg One-Step Arm Protectors Low Profile40440404402026-04-30
0078755104154580566 Camel Mat - Ultra Absorbent Mat (Large) w/ Adhesive80566805662026-04-30
0078755104155280564 Camel Mat - Ultra Absorbent Mat (Extra Large) w/ Adhesive80564805642026-04-30
00787551041569CL25312 Custom Med Label PackCL25312CL253122026-04-30
0078755104157640672 Hot Pink Pad XL40672406722026-04-30
00787551041583SPK11715 Jackson KitSPK11715SPK117152026-04-30
0078755104159040673 Hot Pink Pad EXT - with Arm Protectors40673406732026-04-30
0078755104160640674 Hot Pink Pad EXT40674406742026-04-30
00787551041613SPK11759 Jackson Table KitSPK11759SPK117592026-04-30
00787551041385LPK10033 Lateral Positioning KitLPK10033LPK100332026-01-20
00787551041392LPK10034 Lateral Positioning KitLPK10034LPK100342026-01-20
20787551041389LPK10033 Lateral Positioning KitLPK10033LPK100332026-01-20
20787551041396LPK10034 Lateral Positioning KitLPK10034LPK100342026-01-20
00787551012965SPK11695 Surgical Back Pack KitSPK11695SPK116952025-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09332017002991CocoonCARE ESSENTIALS PTY LTDDWJ2026-04-29
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10197344129072MEDLINEMEDLINE INDUSTRIES, INC.DWJ2025-05-07
10197344129089MEDLINEMEDLINE INDUSTRIES, INC.DWJ2025-05-07
08719867002639Mistral-AirThe Surgical Company International B.V.DWJ2025-01-30
08719867002653Mistral-AirThe Surgical Company International B.V.DWJ2025-01-30
09332017002861CocoonCARE ESSENTIALS PTY LTDDWJ2024-12-20
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09332017003295CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
09332017003301CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
09332017003318CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
09332017003325CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
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09332017003349CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
08719867002646Mistral-Air®The Surgical Company International B.V.DWJ2024-07-08
08719867002660Mistral-Air®The Surgical Company International B.V.DWJ2024-07-08
10193489134773MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10193489134780MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10193489134797MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
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10197344012817MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10197344012831MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10197344013401MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10197344012794MedlineMEDLINE INDUSTRIES, INC.DWJ2024-04-30
09332017002885CocoonCARE ESSENTIALS PTY LTDDWJ2023-01-20
09332017002892CocoonCARE ESSENTIALS PTY LTDDWJ2023-01-20
09332017000645CocoonCARE ESSENTIALS PTY LTDDWJ2021-08-04
09332017002168CocoonCARE ESSENTIALS PTY LTDDWJ2021-08-04
09332017001178CocoonCARE ESSENTIALS PTY LTDDWJ2021-06-01