FDA UDI
Not in Commercial Distribution
🇺🇸 United States
OBALON® Inflation Can
DI: 00859810006210
·
Model: 8200-0001
·
Reshape Lifesciences Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- OBALON® Inflation Can
- Primary DI
- 00859810006210
- Version / Model
- 8200-0001
- Company Name
- Reshape Lifesciences Inc.
- Labeler DUNS
- 022894714
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-11
- Public Version
- 3
- Public Version Date
- 2023-09-01
- Public Version Status
- Update
- Public Device Record Key
- 5ba7ce5d-2d12-48c2-aae7-e2c361fb1bda
- Distribution End Date
- 2020-03-02
Device Description
OBALON® Inflation Can - component to inflate the OBALON® Balloon System
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 Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| 63343 | Appetite-suppression gastric balloon inflation gas cartridge | A small container prefilled with a mixture of medical grade sulphur hexafluoride (SF6) and nitrogen at high pressure intended to be used with a dedicated regulator to inflate an appetite-suppression gastric balloon in situ (i.e., in the stomach). It is a metal device with a valve, and is not intended to be refilled. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10859810006217 | GS1 | 10 | Not in Commercial Distribution | 2020-03-02 | |
| Primary | 00859810006210 | GS1 |
Customer Contacts
- Phone
- 1-844-362-2566
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry, Storage Altitude: 0 to 12,000ft (0 to 3,658m), Storage Temperature Limits: 32 to 104 degrees F (0 to 40 degrees C)
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 85 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 104 Degrees Fahrenheit