FDA.reportPublic FDA data

Dabir Accessories

Primary DI
00851343006187
Brand
Dabir Accessories
Company
DABIR SURFACES, INC.
Model
CA-9004
Device description
Narrow Bedrail Hanger Accessory
Published
2016-06-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

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
00851343006187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851343006187008513430061878513430061870851343006187

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079374086
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00851343006668Dabir MicropressureDA-101884-05-0H2019-05-15
00851343006675Dabir MicropressureDA-102340-01-0H2019-05-15
00851343006682Dabir MicropressureDA-102340-05-0H2019-05-15
00851343006699Dabir MicropressureDA-102624-05-0H2019-05-15
00851343006705Dabir MicropressureDA-102624-01-0H2019-05-15

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Primary DI, Brand, Company table
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