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) (6) PUMP, INFUSION, INSULIN (LZG) (3)

Premarket Exempt

Clear

OneTouch Ping - 10840406101034 Catalog Number : 10543400

Device Description : OTP PUMP W/O KIT, PGL, US

Device Class : 2

Duns Number: 968998641

Premarket Exempt : No

Product Code : LZG

Prescription Use : Yes

Device Count : 1

OneTouch Ping - 10840406101058 Catalog Number : 10543200

Device Description : OTP PUMP W/O KIT, SIL, US

Device Class : 2

Duns Number: 968998641

Premarket Exempt : No

Product Code : LZG

Prescription Use : Yes

Device Count : 1

OneTouch Ping - 10840406101126 Catalog Number : 10050000

Device Description : Pump Kit, Loaner Ping, Any Color

Device Class : 2

Duns Number: 968998641

Premarket Exempt : No

Product Code : LZG

Prescription Use : Yes

Device Count : 1

Animas Vibe - 10840406103106 Catalog Number : 13920000

Device Description : Insulin Pump Replacement, Refurb, Adult, Blue

Device Class : 3

Duns Number: 968998641

Premarket Exempt : No

Product Code : OYC

Prescription Use : Yes

Device Count : 1

Animas Vibe - 10840406103137 Catalog Number : 13920000

Device Description : Insulin Pump w/o Kit, Refurb, Adult, Black

Device Class : 3

Duns Number: 968998641

Premarket Exempt : No

Product Code : OYC

Prescription Use : Yes

Device Count : 1

Animas Vibe - 10840406103168 Catalog Number : 13920000

Device Description : Insulin Pump w/o Kit, Refurbished, Adult, Silver

Device Class : 3

Duns Number: 968998641

Premarket Exempt : No

Product Code : OYC

Prescription Use : Yes

Device Count : 1

Animas Vibe - 10840406103199 Catalog Number : 13920000

Device Description : Insulin Pump w/o Kit, Refurbished, Adult, Pink

Device Class : 3

Duns Number: 968998641

Premarket Exempt : No

Product Code : OYC

Prescription Use : Yes

Device Count : 1

Animas Vibe - 10840406103229 Catalog Number : 13920000

Device Description : Insulin Pump w/o Kit, Refurbished, Adult, Green

Device Class : 3

Duns Number: 968998641

Premarket Exempt : No

Product Code : OYC

Prescription Use : Yes

Device Count : 1

Animas Vibe - 10840406103823 Catalog Number : 10255100

Device Description : PMP KIT, LOANER, VIBE, ANY COL

Device Class : 3

Duns Number: 968998641

Premarket Exempt : No

Product Code : OYC

Prescription Use : Yes

Device Count : 1

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