AccessGUDID - DEVICE: Patient Warming Mattress (00851446007005)

GUDID

Device Identifier (DI) Information

Brand Name: Patient Warming Mattress
Version or Model: 4003
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VITA HEAT MEDICAL

Primary DI Number: 00851446007005
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021249224 *Terms of Use

Device Description: The Model 4003 Patient Warming Mattress is an electrical patient warming mattress that is connected to a Model 2002 Controller and is powered by Model 100026-PA AC Power Adapter or Model 100026 Battery. The Patient Warming Mattress provides warmth for a patient.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
11989	External electric-heating core temperature regulation system pad	An electrically-heated underlay or overlay intended to provide heat under or over a patient as part of an external electric-heating core temperature regulation system intended to elevate a patient’s core body temperature, typically in surgical and intensive care settings. The underlay/overlay typically contains electrical heating elements or cables supplied with energy by a dedicated control unit. The underlay/overlay is available in a variety of lengths, widths, and thicknesses to accommodate body size and application (e.g., adult/paediatric, full-/partial-body). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWJ	System, Thermal Regulating

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K132454	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 43690373-6626-4eb2-adea-42ce2d3d8eb3
Public Version Date: December 18, 2023
Public Version Number: 4
DI Record Publish Date: September 23, 2016