FDA.reportPublic FDA data

CEGA Innovations, Inc.

Primary DI
00850001780216
Brand
CEGA Innovations, Inc.
Company
Cega Innovations, Inc.
Model
MV750-39
Catalog number
MV750-39
Device description
"HALO Single Patient Use (SPU) Air Transfer Mattress with Skin Integrity Pad (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
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
00850001780261PackageGS110In Commercial Distribution
00850001780216PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850001780261008500017802618500017802610850001780261
00850001780216008500017802168500017802160850001780216

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

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
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
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
16931918119823AllesetGRI Medical & Electronic Technology Co., Ltd.KME2026-06-04
10304040196660Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196677Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
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
07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCKME2025-11-19
07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCFMR2025-11-19
07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCFMR2025-11-19
07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCKME2025-11-19
10304040193157Henry ScheinHENRY SCHEIN, INC.KME2025-09-03
10197344161249MEDLINEMEDLINE INDUSTRIES, INC.FMR2025-07-11
10193489021141MEDLINEMEDLINE INDUSTRIES, INC.FMR2025-02-14
10603354120669ComfortTopEHOB INCKME2025-01-22
10193489000658MEDLINEMEDLINE INDUSTRIES, INC.FMR2025-01-03
10603354130200BAMEHOB INCFMR2024-09-12
10603354130248BAMEHOB INCFMR2024-09-12
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