FDA.reportPublic FDA data

CEGA Innovations, Inc.

Primary DI
00850001780353
Brand
CEGA Innovations, Inc.
Company
Cega Innovations, Inc.
Model
MV2008
Catalog number
MV2008
Device description
REMUV Single Patient Use (SPU) Air Transfer Mattress with Skin Integrity Pad (Approx. 36" W x 83" L)
Published
2026-03-12
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
true

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
00850001780353PackageGS110In Commercial Distribution
00850001780346PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850001780353008500017803538500017803530850001780353
00850001780346008500017803468500017803460850001780346

GMDN Terms#

Term, Definition table
TermDefinition
Inflatable patient transfer sliding mattress, single-useAn inflatable device designed to: 1) support a recumbent patient on a bed or table; and 2) assist healthcare professionals in the physical movement and transfer of a patient (e.g., hospitalized, disabled, geriatric) from one place to another using sliding techniques; some types may additionally be designed to provide skin protection to prevent pressure sores and/or support a patient in a specific position (e.g., Trendelenburg). It includes patient straps, handles for transfer, air hose inlets, and requires a pump (not included) for inflation; it is not intended for patient lifting. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length83Inch
Width36Inch

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
true
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
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
00850001780155CEGA Innovations, Inc.MV261MV2612022-12-07

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16931918149158HALYARDGRI Medical & Electronic Technology Co., Ltd.KME2024-06-11