AccessGUDID - DEVICE: AQUARI SURFACE 32 x 16 x 3.5 PEDI (00842430115882)

GUDID

Device Identifier (DI) Information

Brand Name: AQUARI SURFACE 32 x 16 x 3.5 PEDI
Version or Model: 246-PEDIHEART
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 246-PEDIHEART
Company Name: MIZUHO ORTHOPEDIC SYSTEMS, INC.

Primary DI Number: 00842430115882
Issuing Agency: GS1
Commercial Distribution End Date: April 10, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 084527241 *Terms of Use

Device Description: No description.

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
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?
65167	Operating table patient pressure distribution monitoring/regulation system	An assembly of devices designed to monitor and regulate a patient’s body pressure distribution on an operating table mattress to reduce the risk of soft tissue strain and pressure injuries during a surgical procedure. The device consists of: 1) a pressure-sensing mattress which detects surface pressure distribution and feedbacks this information to; 2) an electrically-powered control/pump unit designed to analyse the patient’s volumetric shape variations and inflate/deflate the mattress accordingly.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FNM	Mattress, Air Flotation, Alternating Pressure

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: e85ce79e-de9f-4a03-b11a-6305f660e659
Public Version Date: November 25, 2024
Public Version Number: 2
DI Record Publish Date: July 09, 2021