FDA.reportPublic FDA data

CEGA Innovations, Inc.

Primary DI
00850001780025
Brand
CEGA Innovations, Inc.
Company
Cega Innovations, Inc.
Model
MV750-50
Catalog number
MV750-50
Device description
"HALO Single Patient Use (SPU) Air Transfer Mattress with Skin Integrity Pad (Approx. 50"" W x 78"" L)"
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMRDevice, Transfer, Patient, Manual
KMEBedding, Disposable, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMRDevice, Transfer, Patient, ManualGeneral Hospital1
KMEBedding, Disposable, MedicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850001780223PackageGS15In Commercial Distribution
00850001780025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850001780223008500017802238500017802230850001780223
00850001780025008500017800258500017800250850001780025

GMDN Terms#

Term, Definition table
TermDefinition
Patient transfer system, manualA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length78Inch
Width50Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
605-271-9241info@cegaco.com

Regulatory Flags#

DUNS number
057657531
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850001780346CEGA Innovations, Inc.MV2008MV20082026-03-12
00850001780360CEGA Innovations, Inc.MV2028MV20282026-03-12
00850001780353CEGA Innovations, Inc.MV2008MV20082026-03-12
00850001780377CEGA Innovations, Inc.MV2028MV20282026-03-12
00850001780001CEGA Innovations, Inc.MV750-34MV750-342022-12-07
00850001780032CEGA Innovations, Inc.MV800MV8002022-12-07
00850001780148CEGA Innovations, Inc.MV261MV2612022-12-07
00850001780186CEGA Innovations, Inc.MV200MV2002022-12-07
00850001780209CEGA Innovations, Inc.MV820MV8202022-12-07
00850001780216CEGA Innovations, Inc.MV750-39MV750-392022-12-07
00850001780247CEGA Innovations, Inc.MV260MV2602022-12-07
00850001780285CEGA Innovations, Inc.MV262MV2622022-12-07
00850001780308CEGA Innovations, Inc.MV760-39MV760-392022-12-07
00850001780322CEGA Innovations, Inc.MV760-50MV760-502022-12-07
00850001780278CEGA Innovations, Inc.MV750-34MV750-342022-12-07
00850001780223CEGA Innovations, Inc.MV750-50MV750-502022-12-07
00850001780162CEGA Innovations, Inc.MV800MV8002022-12-07
00850001780087CEGA Innovations, Inc.MV600MV6002022-12-07
00850001780117CEGA Innovations, Inc.MV110MV1102022-12-07
00850001780155CEGA Innovations, Inc.MV261MV2612022-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160538937HalyardMEDICAL ACTION INDUSTRIES INC.KME2026-09-24
00816317024499HoverMatt Lateral Transfer MatRENU MEDICAL, INCFMR2026-09-21
00860012736034Prism Lift Seated SlingPrism Pacific Industries LLCFMR2026-08-27
00860012736072Prism Lift Seated SlingPrism Pacific Industries LLCFMR2026-08-27
00860012736089Prism Lift Seated SlingPrism Pacific Industries LLCFMR2026-08-27
00860015694775Prism SlidePrism Pacific Industries LLCFMR2026-08-27
00860015694782Prism SlidePrism Pacific Industries LLCFMR2026-08-27
00860015694799Prism Microclimate PadPrism Pacific Industries LLCKME2026-08-27
04260647540321TECOtherm Wrabbit +transTec Com Medizintechnik GmbHKME2026-08-26
04260647540345TECOtherm Wrabbit +transTec Com Medizintechnik GmbHKME2026-08-26
04260647540369TECOtherm Wrabbit +transTec Com Medizintechnik GmbHKME2026-08-26
00199972000535CuraplexBOUND TREE MEDICAL, LLCKME2026-08-15
00199972000559CuraplexBOUND TREE MEDICAL, LLCKME2026-08-15
00199972000573CuraplexBOUND TREE MEDICAL, LLCKME2026-08-15
00199536930308BluelineTransparent Supply Solutions Ltd.FMR2026-08-07
00199536930315BluelineTransparent Supply Solutions Ltd.FMR2026-08-07
00199536930322BluelineTransparent Supply Solutions Ltd.FMR2026-08-07
00199536930339BluelineTransparent Supply Solutions Ltd.FMR2026-08-07
00199536930346BluelineTransparent Supply Solutions Ltd.FMR2026-08-07
00840117349551Drape Sheets, Polypropylene/Polyethylene 2-ply, Black, 40" x 90" (101.6 cm x 228Dynarex CorporationKME2026-07-31
00840117350069Pillow Cases, Polypropylene/Polyethylene 2-ply, Black, 21" x 30"Dynarex CorporationKME2026-07-31
06973717276928GARVEEFoshan Dahao Medical Technology Co., Ltd.FMR2026-07-29
00840456201435JMUJMU DENTAL, INCKME2026-07-06
00840456206362JMUJMU DENTAL, INCKME2026-07-06
00840117349544Drape Sheets, Tissue / Poly 2-ply, Black, 40" x 90" (101.6 cm x 228.6 cm)Dynarex CorporationKME2026-06-08
00840117349568Pillow Cases, Tissue / Poly 2-ply, Black, 21" x 30" (53.3 cm x 76.2 cm)Dynarex CorporationKME2026-06-08
16931918119823AllesetGRI Medical & Electronic Technology Co., Ltd.KME2026-06-04
00199536911109BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911116BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911123BluelineTransparent Supply Solutions Ltd.KME2026-05-15