FDA.report

Pivot Rail

Primary DI
00616784046914
Brand
Pivot Rail
Company
DYNAREX CORPORATION
Model
10469
Published
2019-03-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FNLBed, Ac-Powered Adjustable Hospital

Product Code Classifications

CodeDeviceSpecialtyClass
FNLBed, Ac-Powered Adjustable HospitalGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784046914PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784046914006167840469146167840469140616784046914

GMDN Terms

TermDefinition
BedrailA rigid, adjustable device that is mounted to the side or sides of a medical bed and, when in an "up" position, identifies the edge of the mattress support platform, providing a physical barrier intended to reduce the risk of accidental patient falls out of the bed. It may also enable the patient to independently sit up and/or change position while in bed. It may be a detachable component of the bed or integral to the overall construction of the bed. It is typically made of metal and/or plastic materials and is constructed to either lower or fold when the occupant vacates the bed or when not in use. It is not intended to be a patient restraint.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
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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