ANIMAS CORPORATION

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Pump, infusion, insulin, to be used with invasive glucose sensor (OYC) (9) GLUCOSE OXIDASE, GLUCOSE (CGA) (1) PUMP, INFUSION, INSULIN (LZG) (1)

Premarket Exempt

Clear

OneTouch Ping - 00353885010207 Catalog Number :

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

Device Class : 2

Duns Number: 968998641

Premarket Exempt : No

Product Code : LZG, CGA

Prescription Use : Yes

Device Count : 1

Animas Vibe - 10840406100013 Catalog Number : 11420000

Device Description : Insulin Pump & CGM System, Adult Blue

Device Class : 3

Duns Number: 968998641

Premarket Exempt : No

Product Code : OYC

Prescription Use : Yes

Device Count : 1

Animas Vibe - 10840406100020 Catalog Number : 11420400

Device Description : Insulin Pump & CGM System, Adult Pink

Device Class : 3

Duns Number: 968998641

Premarket Exempt : No

Product Code : OYC

Prescription Use : Yes

Device Count : 1

Animas Vibe - 10840406100037 Catalog Number : 11420200

Device Description : Insulin Pump & CGM System, Adult Silver

Device Class : 3

Duns Number: 968998641

Premarket Exempt : No

Product Code : OYC

Prescription Use : Yes

Device Count : 1

Animas Vibe - 10840406100044 Catalog Number : 11451000

Device Description : Insulin Pump Replacement, Adult Blue

Device Class : 3

Duns Number: 968998641

Premarket Exempt : No

Product Code : OYC

Prescription Use : Yes

Device Count : 1

Animas Vibe - 10840406100051 Catalog Number : 11451100

Device Description : Insulin Pump Replacement, Adult Black

Device Class : 3

Duns Number: 968998641

Premarket Exempt : No

Product Code : OYC

Prescription Use : Yes

Device Count : 1

Animas Vibe - 10840406100068 Catalog Number : 11451400

Device Description : Insulin Pump Replacement, Adult Pink

Device Class : 3

Duns Number: 968998641

Premarket Exempt : No

Product Code : OYC

Prescription Use : Yes

Device Count : 1

Animas Vibe - 10840406100075 Catalog Number : 11451500

Device Description : Insulin Pump Replacement, Adult Green

Device Class : 3

Duns Number: 968998641

Premarket Exempt : No

Product Code : OYC

Prescription Use : Yes

Device Count : 1

Animas Vibe - 10840406100082 Catalog Number : 11451200

Device Description : Insulin Pump Replacement, Adult Silver

Device Class : 3

Duns Number: 968998641

Premarket Exempt : No

Product Code : OYC

Prescription Use : Yes

Device Count : 1

Animas Vibe - 10840406100099 Catalog Number : 11420100

Device Description : Insulin Pump & CGM System, Adult Black

Device Class : 3

Duns Number: 968998641

Premarket Exempt : No

Product Code : OYC

Prescription Use : Yes

Device Count : 1

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