FDA.report

DabirAir Accessories

Primary DI
00851343006149
Brand
DabirAir Accessories
Company
DABIR SURFACES, INC.
Model
CA-9002-10
Device description
10' Power Cord Accessory - CE
Published
2016-06-14
Public version status
Update
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
00851343006149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00851343006149008513430061498513430061490851343006149

GMDN Terms

TermDefinition
Basic power supplyA device designed to receive alternating-current energy (AC-power) from a mains electricity power line and deliver one or more regulated direct-current outputs to supply devices with electrical energy. It typically consists of a step-up or step-down transformer, a rectifier, a filter, and an electronic regulator that keeps the voltage, current, or power output stable over a broad range of loads and input voltages.

Device Sizes

TypeValueUnit
Length10Feet

Storage And Handling

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

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
true
Serial number
false
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

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