ANIMA

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3009698294	3009698294	Animas LLC	1	N	2020-04-25	965 Chesterbrook Boulevard Wayne PA US 19087
3014680750	3014680750	Animal Health Logistics	1	Y	2020-04-25	3850 Twin Creeks Drive Columbus OH US 43204

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 GUDID	Product	Phone	Email
00353885010207	OneTouch 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)937-7867	XX@XX.XX
10840406100051	Animas Vibe - Insulin Pump Replacement, Adult Black	+1(877)937-7867	xx@xx.xx
10840406100105	Animas Vibe - Insulin Pump & CGM System, Adult Green	+1(877)937-7867	xx@xx.xx
10840406100129	Animas 2.0 mL Cartridge - CARTRIDGE, STAMPED (ETO STERILE SGL)	+1(877)937-7867	xx@xx.xx
10840406100181	Animas Vibe - REV KIT, VIBE, ADULT, BLU, mg, US	+1(877)937-7867	xx@xx.xx
10840406100198	Animas Vibe - REP KIT, VIBE, ADULT, BLU,mg,US	+1(877)937-7867	xx@xx.xx
10840406100204	Animas Vibe - REP KIT, VIBE, ADULT, BLK,mg,US	+1(877)937-7867	xx@xx.xx

xx.xx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
141888	1233818171	P130007	ANIMAS VIBE SYSTEM	OYC	2014-11-25
141888	1341078241	K984527	IN TOUCH DIABETES MANAGEMENT SOFTWARE	CGA	1999-04-29
141888	1656181878	K081318	ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM	NBW	2008-06-09
141888	1582223223	K080639	SYMPHONY GLUCOSE MANAGEMENT SYSTEM	LZG	2008-06-24
141888	1981316542	K080587	EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE	MRZ	2008-05-15
141888	1002056461	K063674	EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE	LZG	2007-03-30

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
LZG	2	2008-06-24
OYC	1	2014-11-25
NBW	1	2008-06-09
MRZ	1	2008-05-15
CGA	1	1999-04-29

PMA#

Animas Vibe System

2018-07-11

ANIMAS CORP.

Animas Vibe System

2018-04-18

ANIMAS CORP.

Animas Vibe System

2018-03-12

ANIMAS CORP.

Animas Vibe System

2018-03-01

ANIMAS CORP.

Animas Vibe System

2017-10-27

ANIMAS CORP.

Animas Vibe System

2017-10-24

ANIMAS CORP.

Animas Vibe System

2017-08-17

ANIMAS CORP.

Animas, Vibe System

2017-06-09

ANIMAS CORP.

Animas Vibe System

2017-04-21

ANIMAS CORP.

Animas Vibe System

2017-04-20

ANIMAS CORP.

OneTouch Vibe™ Plus System

2016-12-16

ANIMAS CORP.

ANIMAS VIBE SYSTEM

2016-11-05

ANIMAS CORP.

ANIMAS VIBE SYSTEM

2016-11-05

ANIMAS CORP.

ANIMAS VIBE SYSTEM

2016-09-15

ANIMAS CORP.

ANIMAS VIBE SYSTEM

2016-08-24

ANIMAS CORP.

ANIMAS VIBE SYSTEM

2016-07-06

ANIMAS CORP.

ANIMAS VIBE SYSTEM

2016-06-30

ANIMAS CORP.

ANIMAS VIBE SYSTEM

2016-06-16

ANIMAS CORP.

ANIMAS VIBE SYSTEM

2016-06-01

ANIMAS CORP.

ANIMAS VIBE SYSTEM

2016-05-12

ANIMAS CORP.

ANIMAS VIBE SYSTEM

2016-03-02

ANIMAS CORP.

ANIMAS VIBE SYSTEM

2015-12-24

ANIMAS CORP.

ANIMAL VIBE SYSTEM

2015-11-03

ANIMAS CORP.

ANIMAS VIBE SYSTEM

2015-10-30

ANIMAS CORP.

ANIMAS VIBE SYSTEM

2015-10-21

ANIMAS CORP.

ANIMAS VIBE SYSTEM

2015-09-24

ANIMAS CORP.

ANIMAS VIBE SYSTEM

2015-08-18

ANIMAS CORP.

ANIMAS VIBE SYSTEM

2015-08-10

ANIMAS CORP.

ANIMAS VIBE SYSTEM

2015-06-22

ANIMAS CORP.

ANIMAS VIBE SYSTEM

2015-04-14

ANIMAS CORP.

ANIMAS VIBE SYSTEM

2014-11-25

ANIMAS CORP.

PMN#

SYMPHONY GLUCOSE MANAGEMENT SYSTEM

2008-06-24

ANIMAS CORP.

EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE

2008-05-15

ANIMAS CORP.

EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE

2007-03-30

ANIMAS CORP.

ANIMAS MODEL IR1250 INSULIN INFUSION PUMP

2004-12-10

ANIMAS CORP.

MODEL IR 1200 INSULIN PUMP

2003-10-16

ANIMAS CORP.

EZMANAGER PLUS

2003-06-05

ANIMAS CORP.

ANIMUS EZSERTER INFUSION SET INSERTER

2002-06-04

ANIMAS CORP.

MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO

2002-05-29

ANIMAS CORP.

R1000 SERIES INSULIN PUMP

2000-02-10

ANIMAS CORP.

ANIMAL SERUM PRODUCTS

1981-04-08

ANIMAL HEALTH LABORATORIES, INC.

Applications#

086880

ANIMA

084754

ANIMA

070052

ANIMA

GUDID#

OneTouch Ping - OneTouch Ping Blood Glucose Management System For self-testing. For Quantitative measurement of glucose in whole blood. For in vitro diagnostic use only

ANIMAS CORPORATION

2017-09-13

Animas Vibe - Insulin Pump Replacement, Adult Black

ANIMAS CORPORATION

2015-09-17

Animas Vibe - Insulin Pump & CGM System, Adult Green

ANIMAS CORPORATION

2015-09-17

Animas Vibe - REP KIT, VIBE PEDS, P2 (OLDER), SIL, mg, US

ANIMAS CORPORATION

2015-11-16

Animas 2.0 mL Cartridge - CARTRIDGE, STAMPED (ETO STERILE SGL)

ANIMAS CORPORATION

2015-09-17

Animas Vibe - REV KIT, VIBE, ADULT, BLU, mg, US

ANIMAS CORPORATION

2015-11-24

Animas Vibe - REP KIT, VIBE, ADULT, BLU,mg,US

ANIMAS CORPORATION

2015-11-16

Animas Vibe - REP KIT, VIBE, ADULT, BLK,mg,US

ANIMAS CORPORATION

2015-11-16

Animas Vibe - REP KIT, VIBE, ADULT, SIL,mg,US

ANIMAS CORPORATION

2015-11-16

Animas Vibe - REP KIT, VIBE, ADULT, PGL,mg,US

ANIMAS CORPORATION

2015-11-16

Animas Vibe - REP KIT, VIBE, ADULT, LGN,mg,US

ANIMAS CORPORATION

2015-11-16

Animas Vibe - REV KIT, VIBE, ADULT, BLK, mg, US

ANIMAS CORPORATION

2015-11-16

Animas Vibe - REV KIT, VIBE, ADULT, SIL, mg, US

ANIMAS CORPORATION

2015-11-16

Animas Vibe - REV KIT, VIBE, ADULT, PGL, mg, US

ANIMAS CORPORATION

2015-11-16

Animas Vibe - REV KIT, VIBE, ADULT, LGN, mg, US

ANIMAS CORPORATION

2015-11-16

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

ANIMAS CORPORATION

2015-11-16

Animas Vibe - REP KIT, VIBE PEDS, P2 (OLDER), BLK, mg, US

ANIMAS CORPORATION

2015-11-16

Animas Vibe - REP KIT, VIBE PEDS, P2 (OLDER), PGL, mg, US

ANIMAS CORPORATION

2015-11-16

Animas Vibe - Insulin Pump & CGM System, Adult Black

ANIMAS CORPORATION

2015-09-17

Animas Vibe - Insulin Pump Replacement, Adult Silver

ANIMAS CORPORATION

2015-09-17

Animas Vibe - Insulin Pump Replacement, Adult Green

ANIMAS CORPORATION

2015-09-17

Animas Vibe - Insulin Pump Replacement, Adult Pink

ANIMAS CORPORATION

2015-09-17

Animas Vibe - Insulin Pump Replacement, Adult Blue

ANIMAS CORPORATION

2015-09-17

Animas Vibe - Insulin Pump & CGM System, Adult Silver

ANIMAS CORPORATION

2015-09-17

Animas Vibe - Insulin Pump & CGM System, Adult Pink

ANIMAS CORPORATION

2015-09-17

Animas Vibe - Insulin Pump & CGM System, Adult Blue

ANIMAS CORPORATION

2015-09-17

Animas Vibe - PMP KIT, LOANER, VIBE, ANY COL

ANIMAS CORPORATION

2017-09-21

Animas Vibe - Insulin Pump Replacement, Refurb, Adult, Blue

ANIMAS CORPORATION

2018-01-15

OneTouch Ping - OTP PUMP W/O KIT, BK, US

ANIMAS CORPORATION

2016-08-18

OneTouch Ping - Rev Kit, OTP, LGN, mg/DL, US

ANIMAS CORPORATION

2016-08-18

Animas Vibe - REV KIT, VIBE PEDS P1, BLU,mg,US

ANIMAS CORPORATION

2016-03-14

Animas Vibe - REV KIT, VIBE PEDS,P2 (OLDER), BLU,mg,US

ANIMAS CORPORATION

2015-11-16

Animas 2.0 mL Cartridge - CARTRIDGE, STAMPED (ETO STERILE SGL)

ANIMAS CORPORATION

2015-09-17

Animas Vibe - Insulin Pump & CGM System, Adult Blue

ANIMAS CORPORATION

2015-09-17

OneTouch Ping - OTP PUMP W/O KIT, SIL, US

ANIMAS CORPORATION

2016-08-18

OneTouch Ping - Rev Kit, OTP, SIL, mg/DL, US

ANIMAS CORPORATION

2016-08-19

OneTouch Ping - Rev Kit, OTP, PGL, mg/DL, US

ANIMAS CORPORATION

2016-08-18

OneTouch Ping - Rev Kit, OTP, LGN, mg/DL, US

ANIMAS CORPORATION

2016-08-18

OneTouch Ping - Rev Kit, OTP, BLK, mg/DL, US

ANIMAS CORPORATION

2016-08-18

OneTouch Ping - OTP PUMP W/O KIT, BK, US

ANIMAS CORPORATION

2016-08-18

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