FDA.reportPublic FDA data

Fixation Plate for AbbVie PEG 15 FR

Primary DI
08054083004877
Brand
Fixation Plate for AbbVie PEG 15 FR
Company
ABBVIE INC.
Model
62920
Device description
The saleable unit (device count) is 1, there are 5 fixation plates in the saleable unit
Published
2019-04-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K142793000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142793000AbbVie PEGAbbVie , Inc.2015-01-14KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08054083004877PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08054083004877080540830048778054083004877

GMDN Terms#

Term, Definition table
TermDefinition
Gastrostomy tubeA thin, flexible, percutaneous, hollow tube which may include additional external components (e.g., external tubing, syringe) intended to be percutaneously inserted into the stomach to feed a patient with a physical disability that prevents oral feeding (e.g., a birth defect of the stomach), and/or provide drainage/decompression of the stomach when it is necessary to bypass an obstruction of the stomach outlet into the small intestine. Although noninvasive disposable enteral feeding components may be included, surgical instruments and pharmaceutical agents are not included. 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

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