FDA.reportPublic FDA data

Animas 2.0 mL Cartridge

Primary DI
10840406100136
Brand
Animas 2.0 mL Cartridge
Company
ANIMAS CORPORATION
Model
10012402
Catalog number
10012402
Device description
CARTRIDGE, STAMPED (ETO STERILE SGL)
Published
2015-09-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OYCPump, infusion, insulin, to be used with invasive glucose sensor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OYCPump, Infusion, Insulin, To Be Used With Invasive Glucose SensorUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840406100129PackageGS110Not in Commercial Distribution
10840406100174PackageGS12Not in Commercial Distribution
10840406100136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084040610012910840406100129
1084040610017410840406100174
1084040610013610840406100136

GMDN Terms#

Term, Definition table
TermDefinition
Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithmA portable electronic device designed to provide continuous or intermittent subcutaneous delivery of insulin to a patient with diabetes mellitus, incorporating software to receive glucose status data from a monitor/transmitter and to determine the delivery of insulin based on a continuous scalar algorithm. It may be badge-like, designed to adhere to skin or clothing or worn in a case attached to the belt or carried in a pocket and includes a reservoir, a pumping mechanism, and an infusion-rate controller. It may also allow additional manual administration/infusion and functionality to send data to a remote reporting system.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry
Special Storage Condition, Specify00Store at Room Temperature

Contacts#

Phone, Email table
PhoneEmail
+1(877)937-7867xx@xx.xx

Regulatory Flags#

DUNS number
968998641
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00353885010207OneTouch Ping023-0492017-09-13
10840406100051Animas Vibe11451100114511002015-09-17
10840406100013Animas Vibe11420000114200002015-09-17
10840406100334Animas Vibe11651000116510002015-11-16
10840406100570Animas Vibe11851000118510002016-03-14
10840406100839OneTouch Ping10143500101435002016-08-18
10840406100976OneTouch Ping10543100105431002016-08-18
10840406103106Animas Vibe13920000139200002018-01-15
10840406103823Animas Vibe10255100102551002017-09-21
10840406100112Animas Vibe11420000114200002015-09-17
10840406100020Animas Vibe11420400114204002015-09-17
10840406100037Animas Vibe11420200114202002015-09-17
10840406100044Animas Vibe11451000114510002015-09-17
10840406100068Animas Vibe11451400114514002015-09-17
10840406100075Animas Vibe11451500114515002015-09-17
10840406100082Animas Vibe11451200114512002015-09-17
10840406100099Animas Vibe11420100114201002015-09-17
10840406100105Animas Vibe11420500114205002015-09-17
10840406100129Animas 2.0 mL Cartridge10012402100124022015-09-17
10840406100181Animas Vibe11551000115510002015-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00853052007981t:slim X2 5.x Insulin PumpTandem Diabetes Care, Inc.OYC2021-05-18
00763000423124Paradigm® REAL-TimeMEDTRONIC MINIMED, INC.OYC2020-11-15
00763000423131Paradigm® REAL-Time Revel™MEDTRONIC MINIMED, INC.OYC2020-11-15
00853052007967t:slim X2 5.0 Insulin PumpTandem Diabetes Care, Inc.OYC2018-10-15
00763000161088PARADIGM® REAL-timeMEDTRONIC MINIMED, INC.OYC2018-09-30
00763000161132Paradigm® REAL-Time Revel™MEDTRONIC MINIMED, INC.OYC2018-09-28
00763000164300MiniLink® REAL-TimeMEDTRONIC MINIMED, INC.OYC2018-07-07
10840406103106Animas VibeANIMAS CORPORATIONOYC2018-01-15
10840406103601Animas VibeANIMAS CORPORATIONOYC2018-01-15
10840406103137Animas VibeANIMAS CORPORATIONOYC2018-01-15
10840406103168Animas VibeANIMAS CORPORATIONOYC2018-01-15
10840406103199Animas VibeANIMAS CORPORATIONOYC2018-01-15
10840406103229Animas VibeANIMAS CORPORATIONOYC2018-01-15
00643169933125PARADIGM® REAL-timeMEDTRONIC MINIMED, INC.OYC2017-11-30
00643169933170Paradigm® REAL-Time Revel™MEDTRONIC MINIMED, INC.OYC2017-11-30
20643169786725Enlite ®MEDTRONIC MINIMED, INC.OYC2017-11-25
10840406103823Animas VibeANIMAS CORPORATIONOYC2017-09-21
10840406105261Animas VibeANIMAS CORPORATIONOYC2017-09-21
00853052007257t:slim X2 5.0 Insulin PumpTandem Diabetes Care, Inc.OYC2017-08-28
00853052007271t:slim X2 5.0 Insulin PumpTandem Diabetes Care, Inc.OYC2017-08-28
00853052007295t:slim X2 5.0 Insulin PumpTandem Diabetes Care, Inc.OYC2017-08-28
00853052007318t:slim X2 5.0 Insulin PumpTandem Diabetes Care, Inc.OYC2017-08-28
00853052007226t:slim X2 Cartridge, t:lock, 10 PackTandem Diabetes Care, Inc.OYC2017-08-25
00853052007233t:slim X2 Cartridge, t:lock, 2 PackTandem Diabetes Care, Inc.OYC2017-08-25
20613994598404SOF-SENSOR ®MEDTRONIC MINIMED, INC.OYC2016-10-10
00643169283183Medtronic Guardian™ LinkMEDTRONIC MINIMED, INC.OYC2016-09-23
00643169462724Enlite™ SerterMEDTRONIC MINIMED, INC.OYC2016-08-14
00613994933072Enlite™ SerterMEDTRONIC MINIMED, INC.OYC2016-08-14
00852162004613t:slim G4 Insulin Pump, Reconditioned ReplacementTandem Diabetes Care, Inc.OYC2016-08-11
00852162004750t:slim G4 Insulin Pump, ReconditionedTandem Diabetes Care, Inc.OYC2016-08-11