FDA.reportPublic FDA data

CEGA Innovations, Inc.

Primary DI
00850001780315
Brand
CEGA Innovations, Inc.
Company
Cega Innovations, Inc.
Model
MV760-39
Catalog number
MV760-39
Device description
HALO Reusable Air Transfer Mattress (Approx. 39" 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
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMEBedding, Disposable, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMEBedding, Disposable, MedicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850001780315PackageGS11In Commercial Distribution
00850001780308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850001780315008500017803158500017803150850001780315
00850001780308008500017803088500017803080850001780308

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
Width39Inch

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
057657531
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
00850001780025CEGA Innovations, Inc.MV750-50MV750-502022-12-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160538937HalyardMEDICAL ACTION INDUSTRIES INC.KME2026-09-24
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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
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
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
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00199536911154BluelineTransparent Supply Solutions Ltd.KME2026-05-15
00199536911161BluelineTransparent Supply Solutions Ltd.KME2026-05-15
10304040196660Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
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10304040196684Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196691Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196707Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196714Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
16931918105475AllesetGRI Medical & Electronic Technology Co., Ltd.KME2026-03-18
07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCKME2025-11-19