FDA.reportPublic FDA data

Bard Jejunal Feeding/Gastric Decompression Tube

Primary DI
00801741051678
Brand
Bard Jejunal Feeding/Gastric Decompression Tube
Company
Bard Access Systems, Inc.
Model
000733
Catalog number
000733
Device description
12 Fr Tether J-Tube
Published
2015-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES)

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741051675PackageGS12Not in Commercial Distribution
20801741051672PackageGS115Not in Commercial Distribution
00801741051678PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174105167510801741051675
2080174105167220801741051672
00801741051678008017410516788017410516780801741051678

GMDN Terms#

Term, Definition table
TermDefinition
Gastrojejunostomy tubeA thin, flexible, hollow tube intended to be percutaneously inserted into the stomach, typically through puncture of the abdominal wall and stomach after distention of the stomach by endoscopic methods, with an extended portion inserted through the pylorus into the jejunum, to feed a patient who has a physical disability that prevents oral feeding (e.g., a birth defect or a neuromuscular condition) and/or to provide drainage/decompression for an obstructed stomach; it may also be used to administer medication to a patient. Additional invasive devices used to assist gastrostomy and tube introduction (e.g., guidewire) may be included with the tube. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge12French
Length69Centimeter

Contacts#

Phone, Email table
PhoneEmail
+1(800)545-0890medical.services@crbard.com

Regulatory Flags#

DUNS number
044611812
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741038204MicroEZ Introducer012894501289452016-02-08
00801741038211MicroEZ Introducer012895001289502016-02-08
00801741038228MicroEZ Introducer012896001289602016-02-08
00801741038235MicroEZ Introducer022894502289452016-02-08
00801741038242MicroEZ Introducer022895002289502016-02-08
00801741038259MicroEZ Introducer022896002289602016-02-08
00801741038266Peel-Apart Percutaneous Introducer Kit060111006011102016-02-22
00801741038273Peel-Apart Percutaneous Introducer Kit060111306011132016-02-22
00801741038280Peel-Apart Percutaneous Introducer Kit060111406011142016-02-22
00801741038297Peel-Apart Percutaneous Introducer Kit060111506011152016-02-22
00801741038303Peel-Apart Percutaneous Introducer Kit060115006011502016-02-22
00801741038310Peel-Apart Percutaneous Introducer Kit060116506011652016-02-22
00801741038327Peel-Apart Percutaneous Introducer Kit060117006011702016-02-22
00801741038334Peel-Apart Percutaneous Introducer Kit060771006077102016-02-22
00801741038341Peel-Apart Percutaneous Introducer Kit060777006077702016-02-22
00801741038358Peel-Apart Percutaneous Introducer Kit060778006077802016-02-22
00801741038365MicroEZ Introducer067893506789352016-02-08
00801741038372MicroEZ Introducer067894506789452016-02-08
00801741038389MicroEZ Introducer067895006789502016-02-08
00801741038396MicroEZ Introducer067896006789602016-02-08

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