FDA UDI
In Commercial Distribution
🇺🇸 United States
Allurion™ Filler Kit
DI: 00810010540126
·
Model: FD011-04-US
·
Allurion Technologies, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Allurion™ Filler Kit
- Primary DI
- 00810010540126
- Version / Model
- FD011-04-US
- Catalog Number
- 31
- Company Name
- Allurion Technologies, Inc.
- Labeler DUNS
- 078355007
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-07
- Public Version
- 1
- Public Version Date
- 2026-04-15
- Public Version Status
- New
- Public Device Record Key
- bcf40902-8541-4870-91fd-2205a431a142
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LTI | Implant, Intragastric For Morbid Obesity | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17202 | Appetite-suppression gastric balloon | An 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810010540126 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P250023 | 000 |