FDA.report

Dabir Micropressure

Primary DI
00851343006972
Brand
Dabir Micropressure
Company
DABIR SURFACES, INC.
Model
D2-202624-10-0L
Device description
Surface(26" Wide) - Recovery Chair - Micropressure (10 Foot Hose) - LOW (COUPLER/PVC)
Published
2019-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FNMMattress, Air Flotation, Alternating Pressure

Product Code Classifications

CodeDeviceSpecialtyClass
FNMMattress, Air Flotation, Alternating PressureGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00851343006972PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00851343006972008513430069728513430069720851343006972

GMDN Terms

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

TypeValueUnit
Width26Inch

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature40 Degrees Celsius60 Degrees Celsius

Sterilization Methods

Method

Contacts

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
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
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 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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