FDA.reportPublic FDA data

iSage Rx

Primary DI
00850006610006
Brand
iSage Rx
Company
Amalgam RX, Inc.
Model
Version 2.X
Device description
iSage Rx™ (iSage Rx Basal Insulin Titration)
Published
2020-12-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NDCCalculator, Drug Dose

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDCCalculator, Drug DoseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161865000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161865000iSage Rx (iSage Rx Basal Insulin Titration)Isag Rx, Inc.2017-03-07NDC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850006610006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850006610006008500066100068500066100060850006610006

GMDN Terms#

Term, Definition table
TermDefinition
Pharmaceutical management support software, patient-/professional-useA software package intended to be used by both patients at home and healthcare professionals in a clinical setting to facilitate therapeutic pharmaceutical management decisions (e.g., dosage) by providing suggested regimes for individual patients based on their physical and laboratory data. It is available as a locally-installed program, Internet-based and/or mobile application (e.g., to be used on mobile devices at point-of-care); it is not intended to support anaesthesia administration.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080284502
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860008440129iSage Rx Version 3.x2026-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150002375MiniMed AppMEDTRONIC MINIMED, INC.NDC2026-05-25
00199150002382MiniMed AppMEDTRONIC MINIMED, INC.NDC2026-05-25
00860008440129iSage Rx Amalgam RX, Inc.NDC2026-04-22
B553202153OTC0Conifer Connect DiabetesWELLDOC, INC.NDC2026-03-30
00860015223906UpDocUpDoc Inc.NDC2026-01-13
B553202401OTC0Welldoc RxWELLDOC, INC.NDC2025-12-09
B553202402RX0Welldoc RxWELLDOC, INC.NDC2025-12-09
B553202403OTC0Welldoc RxWELLDOC, INC.NDC2025-12-09
B553202404RX0Welldoc RxWELLDOC, INC.NDC2025-12-09
B553202405RX0Welldoc RxWELLDOC, INC.NDC2025-12-09
00199150047000MiniMed 780G Insulin PumpMEDTRONIC MINIMED, INC.NDC2025-11-08
00199150047024MiniMed 780G Insulin PumpMEDTRONIC MINIMED, INC.NDC2025-11-08
00199150047048MiniMed 780G Insulin pumpMEDTRONIC MINIMED, INC.NDC2025-11-08
00199150047055MiniMed 780G Insulin PumpMEDTRONIC MINIMED, INC.NDC2025-11-08
07649994217037T1D1Comerge AGNDC2025-08-28
10385082000009Omnipod DASH PDMInsulet CorporationNDC2025-08-25
B553202251OTC0WelldocWELLDOC, INC.NDC2025-05-29
B553202252RX0WelldocWELLDOC, INC.NDC2025-05-29
B553202253OTC0WelldocWELLDOC, INC.NDC2025-05-29
B553202254RX0WelldocWELLDOC, INC.NDC2025-05-29
B553202256RX0WelldocWELLDOC, INC.NDC2025-05-29
00763000974589InPenMEDTRONIC MINIMED, INC.NDC2025-04-29
00763000974596InPenMEDTRONIC MINIMED, INC.NDC2025-04-29
B553202145RX0LivingConnected Diabetes RxWELLDOC, INC.NDC2025-04-11
00763000489953InPen Smart Insulin Delivery SystemMEDTRONIC MINIMED, INC.NDC2025-03-08
00763000489960InPen Smart Insulin Delivery SystemMEDTRONIC MINIMED, INC.NDC2025-03-08
00850005949558BioButton (Reprocessed)BIOINTELLISENSE, INC.NDC2025-02-19
00850005949565BioButton (Reprocessed, NF Version)BIOINTELLISENSE, INC.NDC2025-02-19
00860003340639EndoTool IV MONARCH MEDICAL TECHNOLOGIES LLCNDC2025-01-02
B553202141OTC0LivingConnected Diabetes RxWELLDOC, INC.NDC2024-12-04