FDA.reportPublic FDA data

CEGA Innovations, Inc.

Primary DI
00850001780346
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
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
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

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
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00850001780155CEGA Innovations, Inc.MV261MV2612022-12-07

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Primary DI, Brand, Company table
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16931918119823AllesetGRI Medical & Electronic Technology Co., Ltd.KME2026-06-04
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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
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07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCKME2025-11-19
10304040193157Henry ScheinHENRY SCHEIN, INC.KME2025-09-03
10197344161249MEDLINEMEDLINE INDUSTRIES, INC.FMR2025-07-11
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10603354130200BAMEHOB INCFMR2024-09-12
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10603354130262BAMEHOB INCFMR2024-09-12
10603354130286BAMEHOB INCFMR2024-09-12
10603354130309BAMEHOB INCFMR2024-09-12
10603354130323BAMEHOB INCFMR2024-09-03
10603354130347BAMEHOB INCFMR2024-09-03
10603354130361BAMEHOB INCFMR2024-09-03
10603354130446BAMEHOB INCFMR2024-09-03
10603354130514BAMEHOB INCFMR2024-09-03
10603354130521BAMEHOB INCFMR2024-09-03
07613327632835Sage Multi-Position MATSSAGE PRODUCTS, LLCFMR2024-08-12
07613327632835Sage Multi-Position MATSSAGE PRODUCTS, LLCKME2024-08-12
10850053289580SURGYCOSurgyco LLCKME2024-08-09