AbbVie NJ

GUDID 38054083008302

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

ABBVIE INC.

Nasoenteral tube
Primary Device ID38054083008302
NIH Device Record Key4366b3ed-4f49-4e87-9a10-4b9b347ac94c
Commercial Distribution StatusIn Commercial Distribution
Brand NameAbbVie NJ
Version Model Number62903
Company DUNS078458370
Company NameABBVIE INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS138054083008302 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNTTubes, Gastrointestinal (And Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-23
Device Publish Date2019-04-15

Devices Manufactured by ABBVIE INC.

48054083023968 - Skyrizi2022-12-15 The 1.2mL Skyrizi On-Body Injector is designed to be used in conjunction with a pre-filled cartridge assembly containing a 180mg
48054083023234 - Skyrizi2022-07-15 The 2.4mL Skyrizi On-Body Injector is designed to be used in conjunction with a pre-filled cartridge assembly containing a 360mg
38054083008173 - AbbVie Lightweight Vest XS2021-10-27 The Lightweight Vest is designed to carry a CADD-Legacy® 1400 pump. This Lightweight Vest is intended for single-patient use on
38054083008180 - AbbVie Lightweight Vest S2021-10-27 The Lightweight Vest is designed to carry a CADD-Legacy® 1400 pump. This Lightweight Vest is intended for single-patient use on
38054083008197 - AbbVie Lightweight Vest M2021-10-27 The Lightweight Vest is designed to carry a CADD-Legacy® 1400 pump. This Lightweight Vest is intended for single-patient use on
38054083008203 - AbbVie Lightweight Vest L2021-10-27 The Lightweight Vest is designed to carry a CADD-Legacy® 1400 pump. This Lightweight Vest is intended for single-patient use on
38054083008210 - AbbVie Lightweight Vest XL2021-10-27 The Lightweight Vest is designed to carry a CADD-Legacy® 1400 pump. This Lightweight Vest is intended for single-patient use on
38054083008227 - AbbVie Lightweight Vest XXL2021-10-27 The Lightweight Vest is designed to carry a CADD-Legacy® 1400 pump. This Lightweight Vest is intended for single-patient use on

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.