FDA.reportPublic FDA data

40671 Hot Pink Pad XL - with Arm Protectors

Primary DI
00787551041408
Brand
40671 Hot Pink Pad XL - with Arm Protectors
Company
XODUS MEDICAL, INC.
Model
40671
Catalog number
40671
Device description
40671 Hot Pink Pad XL - with Arm Protectors
Published
2026-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
20787551041402PackageGS12In Commercial Distribution
00787551041408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2078755104140220787551041402
00787551041408007875510414087875510414080787551041408

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
Kit
true
Lot or batch
true
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00787551041668LPK10037 Lateral Positioning KitLPK10037LPK100372026-10-19
00787551041675LPK10036 Lateral Positioning KitLPK10036LPK100362026-10-19
00787551041682SPK10756 Surgical BackPack KitSPK10756SPK107562026-10-19
00787551041699NSCL24484 Custom Med Label PackNSCL24484NSCL244842026-10-19
00787551041705NSCL25027 Custom Med Label PackNSCL25027NSCL250272026-10-19
0078755104171240675 Hot Pink Pad XL - with Arm Protectors40675406752026-10-19
00787551041637SPK11761 Jackson Table KitSPK11761SPK117612026-07-27
00787551041644SPK11773 Surgical BackPack KitSPK11773SPK117732026-07-27
00787551041651SPK11774 Surgical BackPack KitSPK11774SPK117742026-07-27
0078755100057330500 Cautery Tip Cleaner30500305002017-05-01
0078755101304740670 Hot Pink Pad Controller (Assembled)40670406702026-04-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
0078755104171240675 Hot Pink Pad XL - with Arm ProtectorsXODUS MEDICAL, INC.DWJ2026-10-19
06951013004124KoZee Warming BlanketJiangmen Dacheng Medical Equipment Co., Ltd.DWJ2026-10-15
06950456323090NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323106NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323113NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323120NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323137NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323144NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323151NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323168NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323175NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323182NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323199NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323205NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323212NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323229NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323236NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323243NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323250NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323267NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323274NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323281NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323298NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323304NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323311NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323328NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323335NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323342NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323359NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323366NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30