OBALON Touch™
GUDID 00859810006203
OBALON Touch™ Dispenser Kit - contains one OBALON Touch™ Dispenser, one OBALON® Balloon Evacuator, 1 Screwdriver, and Batteries
OBALON THERAPEUTICS, INC.
Appetite-suppression gastric balloon inflation regulator| Primary Device ID | 00859810006203 |
| NIH Device Record Key | b09817e5-8c3d-4c0c-8516-8d68ebe5bbb8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OBALON Touch™ |
| Version Model Number | 9300-0001 |
| Company DUNS | 022894714 |
| Company Name | OBALON THERAPEUTICS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00859810006203 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P160001
FDA Product Code
| LTI | Implant, Intragastric For Morbid Obesity |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-11 |
| Device Publish Date | 2019-02-20 |
On-Brand Devices [OBALON Touch™]
| 00859810006203 | OBALON Touch™ Dispenser Kit - contains one OBALON Touch™ Dispenser, one OBALON® Balloon Eva |
| 00859810006104 | OBALON Touch™ Dispenser - component to inflate the OBALON® Balloon |
Trademark Results [OBALON Touch]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OBALON TOUCH 87382066 not registered Live/Pending |
Obalon Therapeutics, Inc. 2017-03-22 |
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