CEGA Innovations, Inc. MV261

GUDID 00850001780155

Breathable Skin Integrity Pad (Approx. 35" W x 59" L) (5 EA/bag)

Cega Innovations, Inc.

Absorbent underpad, non-antimicrobial, single-use Absorbent underpad, non-antimicrobial, single-use Absorbent underpad, non-antimicrobial, single-use Absorbent underpad, non-antimicrobial, single-use
Primary Device ID00850001780155
NIH Device Record Keyefd966c1-94d9-44b6-9134-13bc783a37cf
Commercial Distribution StatusIn Commercial Distribution
Brand NameCEGA Innovations, Inc.
Version Model NumberMV261
Catalog NumberMV261
Company DUNS057657531
Company NameCega Innovations, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone605-271-9241
Emailinfo@cegaco.com
Phone605-271-9241
Emailinfo@cegaco.com
Phone605-271-9241
Emailinfo@cegaco.com
Phone605-271-9241
Emailinfo@cegaco.com

Device Dimensions

Width35 Inch
Length59 Inch
Width35 Inch
Length59 Inch
Width35 Inch
Length59 Inch
Width35 Inch
Length59 Inch

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850001780148 [Primary]
GS100850001780155 [Package]
Contains: 00850001780148
Package: Case [5 Units]
In Commercial Distribution

FDA Product Code

KMEBedding, Disposable, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-15
Device Publish Date2022-12-07

On-Brand Devices [CEGA Innovations, Inc.]

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

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