FDA.reportPublic FDA data

Dabir Micropressure

Primary DI
00851343006576
Brand
Dabir Micropressure
Company
DABIR SURFACES, INC.
Model
D2-3S2665-10-1H
Device description
"G2 Stretcher/Gurney Overlay (26"" Wide)"
Published
2019-05-14
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
00851343006576PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851343006576008513430065768513430065760851343006576

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
Length65Inch
Width26Inch

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
H93338036Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H93338042Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H93338436Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H93338442Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H9336200Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H933PR13051Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2025-12-01
00810055884230ProCair PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884247ProCair PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884254ProCair PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884261ProCair PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884278ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884285ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884292ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884308ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884315ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884322ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884339ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884346ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884353ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884360ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00023601033093CAREX HEALTH BRANDSDrive Devilbiss HealthcareFNM2024-06-13
H93365077Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2024-04-16
H93364565Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2024-02-14
00190885000049MatrixMidtown Investments, LLCFNM2023-01-28
00190885000056MatrixMidtown Investments, LLCFNM2023-01-28
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