FDA.reportPublic FDA data

Animas Vibe

Primary DI
10840406100013
Brand
Animas Vibe
Company
ANIMAS CORPORATION
Model
11420000
Catalog number
11420000
Device description
Insulin Pump & CGM System, Adult Blue
Published
2015-09-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
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
10840406100112Direct MarkingGS10
10840406100013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084040610011210840406100112
1084040610001310840406100013

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
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity100 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
968998641
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00353885010207OneTouch Ping023-0492017-09-13
10840406100051Animas Vibe11451100114511002015-09-17
10840406100136Animas 2.0 mL Cartridge10012402100124022015-09-17
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