FDA.reportPublic FDA data

Waffle Grip Trendelenburg Positioning System a Hot Dog Patient Warming Accessory

Primary DI
00855913001978
Brand
Waffle Grip Trendelenburg Positioning System a Hot Dog Patient Warming Accessory
Company
AUGUSTINE TEMPERATURE MANAGEMENT LLC
Model
A300
Catalog number
A300
Device description
Individually Labeled: Waffle Grip Trendelenburg Positioning System, a Hot Dog Patient Warming Accessory A300Box Labeled: Hot Dog Trendelenburg Positioning Kit Qty 10
Published
2016-09-28
Public version status
Update
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
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
30855913001979PackageGS110In Commercial Distribution
00855913001978PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3085591300197930855913001979
00855913001978008559130019788559130019780855913001978

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
952-746-1720cs@augbiomed.com

Regulatory Flags#

DUNS number
965879187
Device count
1
Lot or batch
true
No natural rubber latex
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
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
00855913001480Hot Dog Chest and Torso Warming BlanketB110B1102016-09-28

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