AccessGUDID - DEVICE: CEGA Innovations, Inc. (00850001780025)

GUDID

Device Identifier (DI) Information

Brand Name: CEGA Innovations, Inc.
Version or Model: MV750-50
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MV750-50
Company Name: Cega Innovations, Inc.

Primary DI Number: 00850001780025
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 057657531 *Terms of Use

Device Description: HALO Single Patient Use (SPU) Air Transfer Mattress with Skin Integrity Pad (Approx. 50" W x 78" L)

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
46148	Patient transfer system, manual	A wheeled stretcher and a mechanism on which a patient can be placed so that the patient can be transferred with minimal disturbance (i.e., without changing horizontal body position, lifting, rolling, or dragging). The device typically includes a patient-transfer mechanism (e.g., mechanical, hydraulic) easy to operate by an attendant with minimal physical effort. It is used in hospitals and other healthcare facilities to reduce injuries to both patients and staff while transferring non-ambulatory, comatose, or neurologically-injured patients between beds, tables, and/or stretchers.	Obsolete	false
61850	Absorbent underpad, non-antimicrobial, single-use	A flat piece of absorbent fabric material [e.g., non-woven polyethylene (PE), cellulose] intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids resulting from surgical procedures, childbirth and/or incontinence; it does not include an antimicrobial agent(s). It is intended to be used in the healthcare facility and in the home. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KME	Bedding, Disposable, Medical
FMR	Device, Transfer, Patient, Manual

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
Storage Environment Humidity: between 10 and 70 Percent (%) Relative Humidity
Storage Environment Temperature: between -40 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Width: 50 Inch
Length: 78 Inch

Device Record Status

Public Device Record Key: 6a484dea-d7b4-4a31-a13b-31568cca1bbc
Public Version Date: December 15, 2022
Public Version Number: 1
DI Record Publish Date: December 07, 2022