ABBVIE INC.

Address:Building 3,Austin,TX,78727,US

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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

Adaptor, Holder, Syringe (IQG) (3) Tubes, Gastrointestinal (And Accessories) (KNT) (2) On-Body Injector (QLF) (1)

Premarket Exempt

No Yes

Clear

Abbvie Fitted Vest XXL - 08054083022482 Catalog Number :

Device Description : The Fitted Vest is designed to carry a CADD-Legacy® 1400 pump. The Fitted Vest i The Fitted Vest is designed to carry a CADD-Legacy® 1400 pump. The Fitted Vest is intended to be an undergarment layer that holds the pump close to the body. The Fitted Vest features a central zipper that rises fully up the torso.

Device Class : 1

Duns Number: 078458370

Premarket Exempt : Yes

Product Code : IQG

Prescription Use : No

Device Count : 1

Abbvie fitted belt - 08054083022499 Catalog Number :

Device Description : The AbbVie Fitted Belt is an accessory to the Duopa/Duodopa system and designed The AbbVie Fitted Belt is an accessory to the Duopa/Duodopa system and designed to carry a CADD-Legacy® 1400 pump and drug filled cassette. It is a sewn fabric pouch with buckled waist belt that can be worn by the patient.

Device Class : 1

Duns Number: 078458370

Premarket Exempt : Yes

Product Code : IQG

Prescription Use : No

Device Count : 1

Abbvie Fitted Vest XXXL - 08054083022529 Catalog Number :

Device Class : 1

Duns Number: 078458370

Premarket Exempt : Yes

Product Code : IQG

Prescription Use : No

Device Count : 1

Y-Connector for AbbVie PEG 20 FR - 28054083004918 Catalog Number :

Device Description : The saleable unit (device count) is 1, there are 5 Y-Connectors in the saleable unit

Device Class : 2

Duns Number: 078458370

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 1

AbbVie NJ - 38054083008302 Catalog Number :

Device Description : The AbbVie NJ is a 10 FR, 152 cm, naso-jejunal (NJ) tube made of white radiopaqu The AbbVie NJ is a 10 FR, 152 cm, naso-jejunal (NJ) tube made of white radiopaque polyurethane. The AbbVie NJ includes a silicone coated Stylet.The saleable unit (device count) is 1, there are 5 NJs in the saleable unit

Device Class : 2

Duns Number: 078458370

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 1

Skyrizi - 48054083023234 Catalog Number :

Device Description : The 2.4mL Skyrizi On-Body Injector is designed to be used in conjunction with a The 2.4mL Skyrizi On-Body Injector is designed to be used in conjunction with a pre-filled cartridge assembly containing a 360mg/2.4mL dose of risankizumab-rzaa drug product. The single use device is designed for subcutaneous injection. The device is pre-sterilized and pre-programmed. The device is co-packaged with the drug product and is not marketed separately.

Device Class : 2

Duns Number: 078458370

Premarket Exempt : No

Product Code : QLF

Prescription Use : Yes

Device Count : 1

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