FDA.reportPublic FDA data

Burn Navigator

Primary DI
B2551120
Brand
Burn Navigator
Company
ARCOS, INC.
Model
H2
Catalog number
1120
Device description
Burn Navigator H2 model
Published
2016-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PDTBurn Resuscitation Decision Support Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PDTBurn Resuscitation Decision Support SoftwareAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121659000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121659000BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS)Arcos, Inc.2013-04-18PDT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B2551120PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Clinical information system web-based application softwareAn application software program designed as an Internet-based information system to support the administrative, clinical, and quality control activities associated with the provision/utilization of healthcare within a specific clinical specialty (e.g., orthopaedics, general surgery, neurology, ophthalmology, oncology, rheumatology, dermatology). It can be available on any web-enabled interface (including mobile devices at point-of-care) and is intended for use by healthcare professionals in a clinical setting.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-542-8025support@arcosmedical.com

Regulatory Flags#

DUNS number
831782672
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B2551125Burn NavigatorH2 Transport11252016-08-27
B2551143Burn NavigatorRX11432018-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B2551143Burn NavigatorARCOS, INC.PDT2018-05-14
B2551125Burn NavigatorARCOS, INC.PDT2016-08-27