FDA.report

Arial U

Primary DI
00840948101021
Brand
Arial U
Company
STANLEY SECURITY SOLUTIONS, INC.
Model
56112
Device description
Arial U Software
Published
2018-03-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IQASystem, Environmental Control, Powered

Product Code Classifications

CodeDeviceSpecialtyClass
IQASystem, Environmental Control, PoweredPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840948101021PrimaryGS10

GMDN Terms

TermDefinition
Medical networking interface unitAn electronic unit or device assembly intended to be used to interface multiple noninvasive devices for digital communication of clinical data, typically from a patient data gathering point (e.g., patient monitor, in vitro diagnostic analyser) to a computer/network server; it is not intended to store data, display data/images, or control other devices. It may be a router, network switch, wireless transmitter and/or receiver, or cellular device intended for wired and/or wireless transmission of data. It is not ambulatory and not patient worn.

Sterilization Methods

Method

Regulatory Flags

DUNS number
196880520
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
false
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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00840948102882CHAIR PAD, 7x15, 14-DAY, 4FT, TABS262002023-10-19
00840948102899Fall monitor263002023-10-19
00840948102905Fall monitor920102023-10-19
00840948102912Fall monitor920202023-10-19
00840948102929Fall monitor262012023-10-19
00840948102936Fall monitor930102023-10-19
00840948102943Fall monitor930202023-10-19
00840948102950Fall monitor26201AS2023-10-19
00840948102967ARIAL541802023-10-19
00840948102639ARIAL2560-543602023-10-18
00840948102813ARIAL2560-59360R2560-59360R2023-10-04
00840948102820ARIAL59361R59361R2023-10-04
00840948102837ARIAL2560-59361R12023-10-04
00840948102844ARIAL59362R59362R2023-10-04
00840948102851ARIAL2560-59362R2560-59362R2023-10-04
00840948102868ARIAL59360R59360R2023-10-04
00840948102530ARIAL1069-543701069-543702022-12-06
00840948102547ARIAL0850-2170850-2172022-12-06

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