FDA.reportPublic FDA data

DabirAir Micropressure

Primary DI
00851343006118
Brand
DabirAir Micropressure
Company
DABIR SURFACES, INC.
Model
DA-3S3584-01-0L
Device description
"MedSurg Overlay (33"" Wide) - CE"
Published
2016-08-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
FNMMattress, Air Flotation, Alternating Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNMMattress, Air Flotation, Alternating PressureGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851343006118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851343006118008513430061188513430061180851343006118

GMDN Terms#

Term, Definition table
TermDefinition
Alternating-pressure bed mattress overlay, reusableA pad or thin mattress, usually full-body length, which is placed on top of a bed mattress and designed with parallel chambers that are alternately filled with forced-air to actively change an occupant's bed contact points, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers), patients with disabilities, or patients with low body fat. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length84Inch
Width35Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature40 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-559-3642Support@dabir-surfaces.com

Regulatory Flags#

DUNS number
079374086
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850008719066Dabir MicropressureDA-102082-30-1H2022-01-27
00850008719097Dabir AccessoriesC2-90102022-01-27
00850008719103Dabir MicropressureD2-3S3384-05-1B2022-01-27
00850008719110Dabir MicropressureD2-3S3384-10-1B2022-01-27
00850008719134Dabir AccessoriesC2-90092022-01-27
00850008719141Dabir ControllersC2-10V12022-01-27
00850008719158Dabir MicropressureD2-5S2650-05-0B2022-01-27
00850008719165Dabir AccessoriesC2-90042022-01-27
00850008719172Dabir MicropressureD2-5S2650-10-0B2022-01-27
00850008719202Dabir MicropressureDA-102046-01-1H2022-01-27
00850008719219Dabir MicropressureDA-102046-05-1H2022-01-27
00850008719226Dabir ControllersC2-10VB2022-01-27
00850008719240Dabir MicropressureD2-3S2665-05-1B2022-01-27
00850008719257Dabir MicropressureD2-3S2665-10-1B2022-01-27
00850008719264Dabir MicropressureD2-3S3366-05-1B2022-01-27
00851343006279DabirAir AccessoriesGA-90B2-102019-05-13
00851343006286DabirAir AccessoriesCA-90G2-102019-05-13
00851343006293DabirAir AccessoriesCA-91A2-072019-05-13
00851343006309DabirAir AccessoriesCL-90B2-102019-05-13
00851343006316DabirAir AccessoriesCA-91A2-152019-05-13

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Primary DI, Brand, Company table
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00190885000063MatrixMidtown Investments, LLCFNM2023-01-28
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00190885000094MatrixMidtown Investments, LLCFNM2023-01-28
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