FDA.reportPublic FDA data

Allurion™ Filler Kit

Primary DI
00810010540126
Brand
Allurion™ Filler Kit
Company
Allurion Technologies, Inc.
Model
FD011-04-US
Catalog number
31
Device description
The Allurion Filler Kit is comprised of the following items:• Filler Bag containing sterilized Filling Fluid and a Septum Port to connect to the Extension Hose.• Extension Hose with a Flow Indicator, a Spike to pierce the Filler Bag Septum Port and a Blue Stopcock to connect to the Delivery Catheter.• A Syringe that, if needed, can be connected to the Delivery Catheter and used to evacuate the Balloon in an emergency.
Published
2026-04-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LTIImplant, Intragastric For Morbid Obesity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LTIImplant, Intragastric For Morbid ObesityUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P250023000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P250023000Allurion™ Gastric Balloon SystemAllurion Technologies, Inc.2026-02-20LTI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810010540126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810010540126008100105401268100105401260810010540126

GMDN Terms#

Term, Definition table
TermDefinition
Appetite-suppression gastric balloonAn implantable device intended to be swallowed or endoscopically inserted into the stomach where it is inflated to reduce stomach volume and facilitate weight loss in overweight/obese patients by restricting the quantity of food consumed through an increased sense of satiety (fullness). It is designed to be inflated/filled with an inert material (e.g., saline, air, nitrogen) in situ, where it remains until it is endoscopically removed or deflates and passes through the bowels. Disposable devices dedicated to introduction/inflation may be included with the balloon.

Regulatory Flags#

DUNS number
078355007
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810010540119Allurion™ Gastric Balloon SystemFS010-16-US302026-04-07
00810010540133Allurion™ StyletFD012-02-US322026-04-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810010540119Allurion™ Gastric Balloon SystemAllurion Technologies, Inc.LTI2026-04-07
00810010540133Allurion™ StyletAllurion Technologies, Inc.LTI2026-04-07
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