PhySoftAMS

Primary DI
00861858000310
Brand
PhySoftAMS
Company
PHYSICIAN SOFTWARE SYSTEMS, LLC
Model
1
Device description
PhySoftAMS® is a software application used to obtain, track and trend patient data pertaining to the management of anemia and to provide a schedule of erythropoiesis-stimulating agent (ESA) dosage recommendations to help achieve and maintain target hemoglobin levels in dialysis patients. PhySoftAMS® is intended to help physicians, nurses, clinicians and anemia managers manage anemia in adult stage 5 chronic kidney disease (CKD) patients.
Published
2026-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
MQSSystem, Hemodialysis, Access Recirculation Monitoring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQSSystem, Hemodialysis, Access Recirculation MonitoringGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232283000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232283000PhySoftAMS®Physician Software Systems, LLC2023-12-14MQS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00861858000303PreviousGS10
00861858000310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00861858000303008618580003038618580003030861858000303
00861858000310008618580003108618580003100861858000310

GMDN Terms#

Term, Definition table
TermDefinition
Nephrology information system application softwareAn application software program, routines, and/or algorithms used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of nephrology services. It is used by renal professionals to track disease progression, manage co-morbidities, and prepare patients for renal therapies such as haemodialysis, peritoneal dialysis, and transplant. It is typically installed into a dedicated information system for nephrology or existing mainframe or decentralized computers/networks.

Regulatory Flags#

DUNS number
078367298
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00861858000303PhySoft AMS12016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860005737512Smart Anemia Manager (SAM)Dosis Inc.MQS2021-03-09
00877466000468TransonicTRANSONIC SYSTEMS INC.MQS2020-10-01
00877466000437TransonicTRANSONIC SYSTEMS INC.MQS2020-10-01
00877466000451TransonicTRANSONIC SYSTEMS INC.MQS2020-10-01
00877466005791TransonicTRANSONIC SYSTEMS INC.MQS2020-10-01
00861858000303PhySoft AMSPHYSICIAN SOFTWARE SYSTEMS, LLCMQS2016-09-26
08774660000466TransonicTRANSONIC SYSTEMS INC.MQS2016-04-28
08774660000473TransonicTRANSONIC SYSTEMS INC.MQS2016-04-28
08774660005799TransonicTRANSONIC SYSTEMS INC.MQS2016-04-28
08774660005805TransonicTRANSONIC SYSTEMS INC.MQS2016-04-28
08774660000428TransonicTRANSONIC SYSTEMS INC.MQS2016-04-21
08774660000435TransonicTRANSONIC SYSTEMS INC.MQS2016-04-21
08774660000442TransonicTRANSONIC SYSTEMS INC.MQS2016-04-21
08774660000459TransonicTRANSONIC SYSTEMS INC.MQS2016-04-21