FDA.reportPublic FDA data

Dabir Accessories

Primary DI
00850008719165
Brand
Dabir Accessories
Company
DABIR SURFACES, INC.
Model
C2-9004
Device description
Replacement fuse drawer kit
Published
2022-01-27
Public version status
New
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
00850008719165PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850008719165008500087191658500087191650850008719165

GMDN Terms#

Term, Definition table
TermDefinition
Alternating-pressure bed mattress overlay systemAn assembly of devices consisting of an alternating-pressure bed mattress overlay and a dedicated pump, which also functions as the control unit, designed to actively alternate a bed 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.

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

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
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
00851343006323DabirAir AccessoriesCA-91A2-102019-05-13

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Primary DI, Brand, Company table
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00810055884360ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00023601033093CAREX HEALTH BRANDSDrive Devilbiss HealthcareFNM2024-06-13
H93365077Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2024-04-16
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00190885000063MatrixMidtown Investments, LLCFNM2023-01-28
00190885000070MatrixMidtown Investments, LLCFNM2023-01-28
00190885000087MatrixMidtown Investments, LLCFNM2023-01-28
00190885000094MatrixMidtown Investments, LLCFNM2023-01-28
00190885000100MatrixMidtown Investments, LLCFNM2023-01-28