FDA.reportPublic FDA data

Hot Dog Trendelenburg Warming Mattress, 89 cm (35in)

Primary DI
00855913001985
Brand
Hot Dog Trendelenburg Warming Mattress, 89 cm (35in)
Company
AUGUSTINE TEMPERATURE MANAGEMENT LLC
Model
U300
Catalog number
U300
Device description
Labeled: Hot Dog Trendelenburg Warming Mattress, 89 cm (35in) U300
Published
2016-09-28
Public version status
Update
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
K092807000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092807000HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103Augustine Biomedical & Design, LLC2009-12-10DWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855913001985PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855913001985008559130019858559130019850855913001985

GMDN Terms#

Term, Definition table
TermDefinition
Electric pad whole-body heating systemAn assembly of mains electricity (AC-powered) devices designed to heat a patient's whole body, to compensate for the loss of normal body heat, with heat generated from an externally applied pad typically containing electrical heating elements or cables. The system includes the pad designed to heat under or over the patient, and a control unit to regulate and monitor the heat. The pads are available in a variety of lengths, widths, and thicknesses to accommodate body size and applications (e.g., adult/paediatric, full-/partial-body). The system is typically used in the operating room (OR), the intensive care unit (ICU), or in neonatal and recovery units.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
952-746-1720cs@augbiomed.com

Regulatory Flags#

DUNS number
965879187
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850011479810Hillrom powered by Augustine Surgical HD208915320891532026-04-23
00855913001848"HotDog Underbody Warming Mattress + Return Electrode, 89 cm (35"")"U530U5302024-09-12
00855913001817"HotDog Underbody Warming Mattress + Return Electrode, 82 cm (32"")"U501U5012023-07-17
00855913001824"HotDog Underbody Warming Mattress + Return Electrode, 127 cm (50"")"U502U5022023-07-17
00855913001978Waffle Grip Trendelenburg Positioning System a Hot Dog Patient Warming AccessoryA300A3002016-09-28
00855913001992HotDog Universal Warming BlanketB500B5002022-10-10
00850011479018HotDog Temperature Management SystemWC71WC712022-05-17
00850011479025HotDog Temperature Management SystemWC77WC772022-05-17
00850011479582Hillrom powered by Augustine Surgical HD208351620835162022-05-17
00850011479599Hillrom powered by Augustine Surgical HD208351820835182022-05-17
00850011479605Hillrom powered by Augustine Surgical HD208351920835192022-05-17
00850011479612Hillrom powered by Augustine Surgical HD208352020835202022-05-17
00850011479629Hillrom powered by Augustine Surgical HD208352120835212022-05-17
00855913001015Hot Dog Patient Warming System ControllerWC02WC022016-09-28
00855913001091Hot Dog Lower Body Warming Blanket, PediatricB203B2032016-09-28
00855913001107Hot Dog Patient Warming System Controller WC01WC01WC012016-09-28
00855913001251Hot Dog Lower Body Warming BlanketB103B1032016-09-28
00855913001268Hot Dog Full Body Warming BlanketB104B1042016-09-28
00855913001381Hot Dog Multi-Position Warming BlanketB105B1052016-09-28
00855913001398Hot Dog Head Warming BlanketB107B1072016-09-28

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Primary DI, Brand, Company table
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