FDA.reportPublic FDA data

AbbVie J

Primary DI
08054083014432
Brand
AbbVie J
Company
ABBVIE INC.
Model
AV062
Device description
The AbbVie J is a 9 FR intestinal (J) tube, 120 cm in length. AbbVie J Tube for 15 FR PEG kit (List Number 62918-001)AbbVie J Tube for 20 FR PEG kit (List Number 0AV062-001)This kit includes (Fig. 1):- AbbVie J Tube with Teflon coated Guide Wire and Blue Guide Wire Lock- Y-Connector for the 15 FR PEG or 20 FR PEG- Fixation Screw (blue: 15 FR or violet: 20 FR) with Outer Ring- Click Adaptor consisting of: - Click Adaptor Cap - Click Adaptor Connector
Published
2019-04-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KNTTubes, Gastrointestinal (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142816000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142816000AbbVie JAbbVie , Inc.2015-01-14KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08054083014432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08054083014432080540830144328054083014432

GMDN Terms#

Term, Definition table
TermDefinition
Jejunostomy tubeA sterile, thin, flexible, hollow tube percutaneously inserted into the jejunum, typically through puncture of the abdominal wall and stomach after distention of the gut by endoscopic methods. It is used to feed a patient who has a physical disability that prevents oral feeding (e.g., a birth defect of the mouth, oesophagus, or stomach, or a neuromuscular condition that affects chewing and swallowing), and/or to provide drainage/decompression for the stomach when it is necessary to bypass a longstanding obstruction of the stomach outlet into the small intestine. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078458370
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08054083007953AbbVie Hip Pack106372021-10-18
08054083007960AbbVie Cross Body Pack106362021-10-18
08054083008103AbbVie Chest Pack106352021-10-18
08054083008110AbbVie Snug Vest XS106332021-10-18
08054083008127AbbVie Snug Vest S106332021-10-18
08054083008134AbbVie Snug Vest M106332021-10-18
08054083008141AbbVie Snug Vest L106332021-10-18
08054083008165AbbVie Snug Vest XXL106332021-10-18
08054083008172AbbVie Lightweight Vest XS106342021-10-19
08054083008189AbbVie Lightweight Vest S106342021-10-19
08054083008196AbbVie Lightweight Vest M106342021-10-19
08054083008202AbbVie Lightweight Vest L106342021-10-19
08054083008219AbbVie Lightweight Vest XL106342021-10-19
08054083008226AbbVie Lightweight Vest XXL106342021-10-19
08054083022413Abbvie Fitted Vest XXXS0AV5512021-09-20
08054083022420Abbvie Fitted Vest XXS0AV5512021-09-17
08054083022444Abbvie Fitted Vest Small0AV5512021-09-17
08054083022451Abbvie Fitted Vest Medium0AV5512021-09-14
08054083022468Abbvie Fitted Vest Large0AV5512021-09-14
08054083022475Abbvie Fitted Vest XL0AV5512021-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00350770997834MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997841MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997858MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997896MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997902MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997919MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997964MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997971MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
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