FDA.reportPublic FDA data

Hot Dog Lower Body Warming Blanket, Pediatric

Primary DI
00855913001091
Brand
Hot Dog Lower Body Warming Blanket, Pediatric
Company
AUGUSTINE TEMPERATURE MANAGEMENT LLC
Model
B203
Catalog number
B203
Device description
Hot Dog Lower Body Warming Blanket, Pediatric B203
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
K112488000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112488000HOTDOG PATIENT WARMING SYSTEMAugustine Biomedical & Design, LLC2011-11-23DWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855913001091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855913001091008559130010918559130010910855913001091

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
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
00855913001480Hot Dog Chest and Torso Warming BlanketB110B1102016-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09332017002991CocoonCARE ESSENTIALS PTY LTDDWJ2026-04-29
09332017004131CocoonCARE ESSENTIALS PTY LTDDWJ2026-02-25
09332017004155CocoonCARE ESSENTIALS PTY LTDDWJ2026-02-25
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
09332017003257CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
09332017003295CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
09332017003301CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
09332017003318CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
09332017003325CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
09332017003332CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
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
10197344012770MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
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