AccessGUDID - DEVICE: DMI (00041298019824)

GUDID

Device Identifier (DI) Information

Brand Name: DMI
Version or Model: 552-1982-0000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 552-1982-0000
Company Name: D-M-S HOLDINGS, INC.

Primary DI Number: 00041298019824
Issuing Agency: GS1
Commercial Distribution End Date: May 17, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 062028220 *Terms of Use

Device Description: PRESSURE PAD ALTERNATING ONLY 32 X 72 IN INFLATED

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):	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?
44192	Alternating-pressure chair cushion, single-use	A pad intended to be placed on the seat of a chair and designed with parallel chambers that are alternately filled with forced-air to actively change an occupant's buttocks-chair contact points, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized patients especially in cases of decubitus ulcers, patients with disabilities, or patients with low body fat. This is a single-use device.	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: 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: 61293738-aa6a-4af2-ba25-c3b7988f6c25
Public Version Date: May 18, 2023
Public Version Number: 3
DI Record Publish Date: September 23, 2016