FDA.reportPublic FDA data

Insulia

Primary DI
03760261310085
Brand
Insulia
Company
VOLUNTIS
Model
Redwing A_1.6_US
Published
2018-08-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
K172177000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172177000Insulia Diabetes Management CompanionVoluntis Sa.2017-11-07NDC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760261310085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760261310085037602613100853760261310085

GMDN Terms#

Term, Definition table
TermDefinition
Pharmaceutical management support softwareA software package designed 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), and is intended for use by patients at home and healthcare professionals in a clinical setting; it is not intended to support anaesthesia administration.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
572684194
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760261310184HeroTracker Sense1.22026-04-21
03760261310009InsuliaRedwing 1WUS2017-08-09
03760261310016InsuliaREdwing 1IUS2017-08-09
03760261310023InsuliaRedwing 1AUS2017-08-09
03760261310061InsuliaRedwing W_1.6_US2018-08-21
03760261310078InsuliaRedwing I_1.6_US2018-08-21

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