FDA UDI
Not in Commercial Distribution
🇺🇸 United States
OBALON Touch™
DI: 00859810006203
·
Model: 9300-0001
·
Reshape Lifesciences Inc.
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OBALON Touch™
- Primary DI
- 00859810006203
- Version / Model
- 9300-0001
- Company Name
- Reshape Lifesciences Inc.
- Labeler DUNS
- 022894714
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-02-20
- Public Version
- 3
- Public Version Date
- 2023-09-01
- Public Version Status
- Update
- Public Device Record Key
- b09817e5-8c3d-4c0c-8516-8d68ebe5bbb8
- Distribution End Date
- 2020-03-02
Device Description
OBALON Touch™ Dispenser Kit - contains one OBALON Touch™ Dispenser, one OBALON® Balloon Evacuator, 1 Screwdriver, and Batteries
Device Characteristics
- Single Use
- No
- 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 Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- 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 |
|---|---|---|---|---|
| 63320 | Appetite-suppression gastric balloon inflation regulator | A battery-powered device intended to regulate the flow of a medical gas (e.g., nitrogen-sulphur hexafluoride) from a small gas canister into an appetite-suppression gastric balloon (not included) during in situ balloon inflation. It is an electronic regulator designed to accept the gas canister (not included), and intended to be connected to the balloon via appropriate tubing/catheter (not included). This is a reusable device. | No | Active |
| 63405 | Appetite-suppression gastric balloon deployment device/set | A non-sterile, noninvasive device/collection of devices intended to be used in conjunction with an inflation regulator (not included) to support deployment of a gastric balloon in the stomach. It may include extension tubing, designed to connect the inflation regulator to the catheter, valves/connectors, or a balloon ejection syringe intended to inject fluid with enough pressure to disconnect the catheter from the balloon once fully inflated in situ; it includes at least one devices dedicated to appetite-suppression gastric balloon deployment. Neither the catheter nor balloon are included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859810006203 | GS1 |
Customer Contacts
- Phone
- 1-844-362-2566
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Storage Environment Temperature
- Temperature Range
- 39 – 104 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 85 Percent (%) Relative Humidity