FDA.reportPublic FDA data

Animas LLC

Matched from indexed company URL: ANIMAS CORP.

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
10840406100051Animas Vibe - Insulin Pump Replacement, Adult Black+1(877)937-7867xx@xx.xx
10840406103137Animas Vibe - Insulin Pump w/o Kit, Refurb, Adult, Black+1(878)937-7867xx@xx.xx
10840406103168Animas Vibe - Insulin Pump w/o Kit, Refurbished, Adult, Silver+1(879)937-7867xx@xx.xx
10840406103199Animas Vibe - Insulin Pump w/o Kit, Refurbished, Adult, Pink+1(880)937-7867xx@xx.xx
10840406103229Animas Vibe - Insulin Pump w/o Kit, Refurbished, Adult, Green+1(881)937-7867xx@xx.xx
10840406103601Animas Vibe - Insulin Pump Replacement, Refurb, Adult, Blue+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#

68 records. Showing 1-40. Next