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Animas LLC

Matched from indexed company URL: ANIMAS CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30096982943009698294Animas LLC1N2020-04-25965 Chesterbrook Boulevard Wayne PA US 19087

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00353885010207OneTouch Ping - OneTouch Ping Blood Glucose Management System For self-testing. For Quantitative measurement of glucose in whole blood. For in vitro diagnostic use only+1(877)937-7867XX@XX.XX
10840406100013Animas Vibe - Insulin Pump & CGM System, Adult Blue+1(877)937-7867xx@xx.xx
10840406100051Animas Vibe - Insulin Pump Replacement, Adult Black+1(877)937-7867xx@xx.xx
10840406100136Animas 2.0 mL Cartridge - CARTRIDGE, STAMPED (ETO STERILE SGL)+1(877)937-7867xx@xx.xx
10840406100334Animas Vibe - REV KIT, VIBE PEDS,P2 (OLDER), BLU,mg,US+1(877)937-7867xx@xx.xx
10840406100570Animas Vibe - REV KIT, VIBE PEDS P1, BLU,mg,US+1(877)937-7867xx@xx.xx
10840406100839OneTouch Ping - Rev Kit, OTP, LGN, mg/DL, US+1(877)937-7867xx@xx.xx
10840406100976OneTouch Ping - OTP PUMP W/O KIT, BK, US+1(877)937-7867xx@xx.xx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1418881233818171P130007ANIMAS VIBE SYSTEMOYC2014-11-25
1418881341078241K984527IN TOUCH DIABETES MANAGEMENT SOFTWARECGA1999-04-29
1418881656181878K081318ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAMNBW2008-06-09
1418881582223223K080639SYMPHONY GLUCOSE MANAGEMENT SYSTEMLZG2008-06-24
1418881981316542K080587EZ MANAGER MAX DIABETES MANAGEMENT SOFTWAREMRZ2008-05-15
1418881002056461K063674EZMANAGER MAX DIABETES MANAGEMENT SOFTWARELZG2007-03-30

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LZG22008-06-24
OYC12014-11-25
NBW12008-06-09
MRZ12008-05-15
CGA11999-04-29

PMA#

PMN#

GUDID#

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