FDA UDI
Not in Commercial Distribution
🇺🇸 United States
OBALON® Balloon Kit HPMC
DI: 00859810006067
·
Model: 7600-0001
·
Reshape Lifesciences Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OBALON® Balloon Kit HPMC
- Primary DI
- 00859810006067
- Version / Model
- 7600-0001
- Company Name
- Reshape Lifesciences Inc.
- Labeler DUNS
- 022894714
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-11
- Public Version
- 7
- Public Version Date
- 2024-01-03
- Public Version Status
- Update
- Public Device Record Key
- 65a08cca-a8c1-4b16-a851-6f0bfd615695
- Distribution End Date
- 2020-03-02
Device Description
Intragastric Balloon
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
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 | 00859810006067 | GS1 |
Customer Contacts
- Phone
- 1-844-362-2566
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P160001 | 003 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C)
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 77 Degrees Fahrenheit