Animas Vibe 11620000

GUDID 10840406100280

REP KIT, VIBE PEDS, P2 (OLDER), BLU, mg, US

ANIMAS CORPORATION

Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm

• Primary Device ID: 10840406100280
• NIH Device Record Key: 22794930-6010-4781-8cbf-f58d0c43dd06
• Commercial Distribution Discontinuation: 2020-07-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Animas Vibe
• Version Model Number: 11620000
• Catalog Number: 11620000
• Company DUNS: 968998641
• Company Name: ANIMAS CORPORATION
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)937-7867
• Email: xx@xx.xx
• Phone: +1(877)937-7867
• Email: xx@xx.xx
• Phone: +1(877)937-7867
• Email: xx@xx.xx
• Phone: +1(877)937-7867
• Email: xx@xx.xx
• Phone: +1(877)937-7867
• Email: xx@xx.xx
• Phone: +1(877)937-7867
• Email: xx@xx.xx
• Phone: +1(877)937-7867
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840406100280 [Primary]

FDA Product Code

• OYC: Pump, infusion, insulin, to be used with invasive glucose sensor

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-08-04
• Device Publish Date: 2015-11-16

On-Brand Devices [Animas Vibe]

• 10840406105261: PMP KIT, LOANER, VIBE, ANY COL
• 10840406103229: Insulin Pump w/o Kit, Refurbished, Adult, Green
• 10840406103199: Insulin Pump w/o Kit, Refurbished, Adult, Pink
• 10840406103168: Insulin Pump w/o Kit, Refurbished, Adult, Silver
• 10840406103137: Insulin Pump w/o Kit, Refurb, Adult, Black
• 10840406103601: Insulin Pump Replacement, Refurb, Adult, Blue
• 10840406100617: REV KIT, VIBE PEDS P1, LGN,mg,US
• 10840406100600: REV KIT, VIBE PEDS P1, PGL,mg,US
• 10840406100594: REV KIT, VIBE PEDS P1, SIL,mg,US
• 10840406100587: REV KIT, VIBE PEDS P1, BLK,mg,US
• 10840406100624: REV KIT, VIBE PEDS P1, BLU,mg,US
• 10840406100563: REP KIT, VIBE PEDS P1, LGN,mg,US
• 10840406100556: REP KIT, VIBE PEDS P1, PGL,mg,US
• 10840406100549: REP KIT, VIBE PEDS P1, SIL,mg,US
• 10840406100532: REP KIT, VIBE PEDS P1, BLK,mg,US
• 10840406100525: REP KIT, VIBE PEDS P1, BLU,mg,US
• 10840406100372: REV KIT, VIBE PEDS,P2 (OLDER), LGN,mg,US
• 10840406100365: REV KIT, VIBE PEDS,P2 (OLDER), PGL,mg,US
• 10840406100358: REV KIT, VIBE PEDS,P2 (OLDER), SIL,mg,US
• 10840406100341: REV KIT, VIBE PEDS,P2 (OLDER), BLK,mg,US
• 10840406100389: REV KIT, VIBE PEDS,P2 (OLDER), BLU,mg,US
• 10840406100327: REP KIT, VIBE PEDS, P2 (OLDER), LGN, mg, US
• 10840406100310: REP KIT, VIBE PEDS, P2 (OLDER), PGL, mg, US
• 10840406100303: REP KIT, VIBE PEDS, P2 (OLDER), SIL, mg, US
• 10840406100297: REP KIT, VIBE PEDS, P2 (OLDER), BLK, mg, US
• 10840406100280: REP KIT, VIBE PEDS, P2 (OLDER), BLU, mg, US
• 10840406100273: REV KIT, VIBE, ADULT, LGN, mg, US
• 10840406100266: REV KIT, VIBE, ADULT, PGL, mg, US
• 10840406100259: REV KIT, VIBE, ADULT, SIL, mg, US
• 10840406100242: REV KIT, VIBE, ADULT, BLK, mg, US
• 10840406100235: REP KIT, VIBE, ADULT, LGN,mg,US
• 10840406100228: REP KIT, VIBE, ADULT, PGL,mg,US
• 10840406100211: REP KIT, VIBE, ADULT, SIL,mg,US
• 10840406100204: REP KIT, VIBE, ADULT, BLK,mg,US
• 10840406100198: REP KIT, VIBE, ADULT, BLU,mg,US
• 10840406100181: REV KIT, VIBE, ADULT, BLU, mg, US
• 10840406100105: Insulin Pump & CGM System, Adult Green
• 10840406100099: Insulin Pump & CGM System, Adult Black
• 10840406100082: Insulin Pump Replacement, Adult Silver
• 10840406100075: Insulin Pump Replacement, Adult Green
• 10840406100068: Insulin Pump Replacement, Adult Pink
• 10840406100044: Insulin Pump Replacement, Adult Blue
• 10840406100037: Insulin Pump & CGM System, Adult Silver
• 10840406100020: Insulin Pump & CGM System, Adult Pink
• 10840406100112: Insulin Pump & CGM System, Adult Blue
• 10840406100051: Insulin Pump Replacement, Adult Black