Plenity™
GUDID 00860517002634
Super-absorbent hydrogel to aid in weight management.
GELESIS, INC.
Ingested gastric satiety device| Primary Device ID | 00860517002634 |
| NIH Device Record Key | eaef4497-f72c-4b53-9ebe-d5b388f10b0b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Plenity™ |
| Version Model Number | MC0420 |
| Company DUNS | 010729307 |
| Company Name | GELESIS, INC. |
| Device Count | 14 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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
| Phone | 1-844-753-6489 |
| info@gelesis.com | |
| Phone | 1-844-753-6489 |
| info@gelesis.com | |
| Phone | 1-844-753-6489 |
| info@gelesis.com | |
| Phone | 1-844-753-6489 |
| info@gelesis.com | |
| Phone | 1-844-753-6489 |
| info@gelesis.com | |
| Phone | 1-844-753-6489 |
| info@gelesis.com | |
| Phone | 1-844-753-6489 |
| info@gelesis.com | |
| Phone | 1-844-753-6489 |
| info@gelesis.com | |
| Phone | 1-844-753-6489 |
| info@gelesis.com | |
| Phone | 1-844-753-6489 |
| info@gelesis.com | |
| Phone | 1-844-753-6489 |
| info@gelesis.com | |
| Phone | 1-844-753-6489 |
| info@gelesis.com | |
| Phone | 1-844-753-6489 |
| info@gelesis.com | |
| Phone | 1-844-753-6489 |
| info@gelesis.com | |
| Phone | 1-844-753-6489 |
| info@gelesis.com | |
| Phone | 1-844-753-6489 |
| info@gelesis.com | |
| Phone | 1-844-753-6489 |
| info@gelesis.com | |
| Phone | 1-844-753-6489 |
| info@gelesis.com | |
| Phone | 1-844-753-6489 |
| info@gelesis.com | |
| Phone | 1-844-753-6489 |
| info@gelesis.com | |
| Phone | 1-844-753-6489 |
| info@gelesis.com | |
| Phone | 1-844-753-6489 |
| info@gelesis.com | |
| Phone | 1-844-753-6489 |
| info@gelesis.com | |
| Phone | 1-844-753-6489 |
| info@gelesis.com | |
| Phone | 1-844-753-6489 |
| info@gelesis.com | |
| Phone | 1-844-753-6489 |
| info@gelesis.com | |
| Phone | 1-844-753-6489 |
| info@gelesis.com | |
| Phone | 1-844-753-6489 |
| info@gelesis.com | |
| Phone | 1-844-753-6489 |
| info@gelesis.com | |
| Phone | 1-844-753-6489 |
| info@gelesis.com | |
| Phone | 1-844-753-6489 |
| info@gelesis.com | |
| Phone | 1-844-753-6489 |
| info@gelesis.com | |
| Phone | 1-844-753-6489 |
| info@gelesis.com | |
| Phone | 1-844-753-6489 |
| info@gelesis.com | |
| Phone | 1-844-753-6489 |
| info@gelesis.com | |
| Phone | 1-844-753-6489 |
| info@gelesis.com | |
| Phone | 1-844-753-6489 |
| info@gelesis.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860517002634 [Unit of Use] |
| GS1 | 00860517002641 [Package] Contains: 10860517002631 Package: Monthly Kit [4 Units] In Commercial Distribution |
| GS1 | 00860517002658 [Package] Contains: 20860517002638 Package: Monthly Kit [4 Units] In Commercial Distribution |
| GS1 | 00860517002665 [Primary] |
| GS1 | 00860517002672 [Primary] |
| GS1 | 10860517002631 [Primary] |
| GS1 | 20860517002638 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- deNovo: DEN180060
FDA Product Code
| QFQ | Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss |
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 | 2020-05-14 |
| Device Publish Date | 2020-05-06 |
On-Brand Devices [Plenity™ ]
| 00860517002627 | Super-absorbent hydrogel to aid in weight management. |
| 00860517002634 | Super-absorbent hydrogel to aid in weight management. |
Trademark Results [Plenity]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PLENITY 87983022 not registered Live/Pending |
Gelesis, Inc. 2017-01-06 |
 PLENITY 87291524 not registered Live/Pending |
Gelesis, Inc. 2017-01-06 |
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