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) (10)

Premarket Exempt

Clear

Animas Vibe - 10840406100365 Catalog Number : 11651400

Device Description : REV KIT, VIBE PEDS,P2 (OLDER), PGL,mg,US

Device Class : 3

Duns Number: 968998641

Premarket Exempt : No

Product Code : OYC

Prescription Use : Yes

Device Count : 1

Animas Vibe - 10840406100372 Catalog Number : 11651500

Device Description : REV KIT, VIBE PEDS,P2 (OLDER), LGN,mg,US

Device Class : 3

Duns Number: 968998641

Premarket Exempt : No

Product Code : OYC

Prescription Use : Yes

Device Count : 1

Animas Vibe - 10840406100525 Catalog Number : 11820000

Device Description : REP KIT, VIBE PEDS P1, BLU,mg,US

Device Class : 3

Duns Number: 968998641

Premarket Exempt : No

Product Code : OYC

Prescription Use : Yes

Device Count : 1

Animas Vibe - 10840406100532 Catalog Number : 11820100

Device Description : REP KIT, VIBE PEDS P1, BLK,mg,US

Device Class : 3

Duns Number: 968998641

Premarket Exempt : No

Product Code : OYC

Prescription Use : Yes

Device Count : 1

Animas Vibe - 10840406100549 Catalog Number : 11820200

Device Description : REP KIT, VIBE PEDS P1, SIL,mg,US

Device Class : 3

Duns Number: 968998641

Premarket Exempt : No

Product Code : OYC

Prescription Use : Yes

Device Count : 1

Animas Vibe - 10840406100556 Catalog Number : 11820400

Device Description : REP KIT, VIBE PEDS P1, PGL,mg,US

Device Class : 3

Duns Number: 968998641

Premarket Exempt : No

Product Code : OYC

Prescription Use : Yes

Device Count : 1

Animas Vibe - 10840406100563 Catalog Number : 11820500

Device Description : REP KIT, VIBE PEDS P1, LGN,mg,US

Device Class : 3

Duns Number: 968998641

Premarket Exempt : No

Product Code : OYC

Prescription Use : Yes

Device Count : 1

Animas Vibe - 10840406100570 Catalog Number : 11851000

Device Description : REV KIT, VIBE PEDS P1, BLU,mg,US

Device Class : 3

Duns Number: 968998641

Premarket Exempt : No

Product Code : OYC

Prescription Use : Yes

Device Count : 1

Animas Vibe - 10840406100587 Catalog Number : 11851100

Device Description : REV KIT, VIBE PEDS P1, BLK,mg,US

Device Class : 3

Duns Number: 968998641

Premarket Exempt : No

Product Code : OYC

Prescription Use : Yes

Device Count : 1

Animas Vibe - 10840406100594 Catalog Number : 11851200

Device Description : REV KIT, VIBE PEDS P1, SIL,mg,US

Device Class : 3

Duns Number: 968998641

Premarket Exempt : No

Product Code : OYC

Prescription Use : Yes

Device Count : 1

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