CEGA Innovations, Inc. MV750-39

GUDID 00850001780261

HALO Single Patient Use (SPU) Air Transfer Mattress with Skin Integrity Pad (Approx. 39" W x 78" L)

Cega Innovations, Inc.

Patient transfer system, manual Patient transfer system, manual Patient transfer system, manual Patient transfer system, manual

• Primary Device ID: 00850001780261
• NIH Device Record Key: dba28ff7-c97c-4b7c-a72b-ae893f020d72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CEGA Innovations, Inc.
• Version Model Number: MV750-39
• Catalog Number: MV750-39
• Company DUNS: 057657531
• Company Name: Cega Innovations, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 605-271-9241
• Email: info@cegaco.com
• Phone: 605-271-9241
• Email: info@cegaco.com
• Phone: 605-271-9241
• Email: info@cegaco.com
• Phone: 605-271-9241
• Email: info@cegaco.com

Device Dimensions

• Length: 78 Inch
• Width: 39 Inch
• Length: 78 Inch
• Width: 39 Inch
• Length: 78 Inch
• Width: 39 Inch
• Length: 78 Inch
• Width: 39 Inch

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850001780216 [Primary]
GS1	00850001780261 [Package]; Contains: 00850001780216; Package: Case [10 Units]; In Commercial Distribution

FDA Product Code

• KME: Bedding, Disposable, Medical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-15
• Device Publish Date: 2022-12-07

On-Brand Devices [CEGA Innovations, Inc.]

• 00850001780339: HALO Reusable Air Transfer Mattress (Approx. 50" W x 78" L)
• 00850001780315: HALO Reusable Air Transfer Mattress (Approx. 39" W x 78" L)
• 00850001780292: Premium Breathable Skin Integrity Pad (Repositioning) (Approx. 40" W x 59" L) (5 EA/bag)
• 00850001780254: Bed Protection Skin Integrity Pad (Approx. 35" W x 72" L) (5 EA/bag)
• 00850001780261: HALO Single Patient Use (SPU) Air Transfer Mattress with Skin Integrity Pad (Approx. 39" W x 78"
• 00850001780230: REMUV LP Single Patient Use (SPU) Air Transfer Mattress with Skin Integrity Pad (Approx. 36" W x
• 00850001780193: Multi-Purpose Pads (Approx. 27" W x 52" L) (10 EA/bag)
• 00850001780155: Breathable Skin Integrity Pad (Approx. 35" W x 59" L) (5 EA/bag)
• 00850001780117: MUV Elite (1 EA/CS)
• 00850001780087: REMUV Air Supply (1 EA/CS)
• 00850001780162: REMUV Single Patient Use (SPU) Air Transfer Mattress with Skin Integrity Pad (Approx. 36" W x 83
• 00850001780223: HALO Single Patient Use (SPU) Air Transfer Mattress with Skin Integrity Pad (Approx. 50" W x 78"
• 00850001780278: HALO Single Patient Use (SPU) Air Transfer Mattress with Skin Integrity Pad (Approx. 34" W x 78"