CEGA Innovations, Inc.

Basic Information

• Brand Name: CEGA Innovations, Inc.
• Primary DI: 00850001780001
• Version / Model: MV750-34
• Catalog Number: MV750-34
• Company Name: Cega Innovations, Inc.
• Labeler DUNS: 057657531
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-07
• Public Version: 1
• Public Version Date: 2022-12-15
• Public Version Status: New
• Public Device Record Key: 2418c99e-28a7-4fb2-b174-fa5e35713916

Device Description

HALO Single Patient Use (SPU) Air Transfer Mattress with Skin Integrity Pad (Approx. 34" W x 78" L)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMR	Device, Transfer, Patient, Manual	General Hospital	880.6785	1
KME	Bedding, Disposable, Medical	General Hospital	880.6060	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00850001780278	GS1	Case	10	In Commercial Distribution
Primary	00850001780001	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Width	34	Inch
Length	78	Inch

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 70 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius