Plenity™
GUDID 00860517002634
Super-absorbent hydrogel to aid in weight management.
GELESIS, INC.
Ingested gastric satiety device Ingested gastric satiety device Ingested gastric satiety device Ingested gastric satiety device Ingested gastric satiety device Ingested gastric satiety device Ingested gastric satiety device Ingested gastric satiety device Ingested gastric satiety device Ingested gastric satiety device Ingested gastric satiety device Ingested gastric satiety device Ingested gastric satiety device Ingested gastric satiety device Ingested gastric satiety device Ingested gastric satiety device Ingested gastric satiety device Ingested gastric satiety device Ingested gastric satiety device Ingested gastric satiety device Ingested gastric satiety device Ingested gastric satiety device Ingested gastric satiety device Ingested gastric satiety device Ingested gastric satiety device Ingested gastric satiety device Ingested gastric satiety device Ingested gastric satiety device Ingested gastric satiety device Ingested gastric satiety device Ingested gastric satiety device Ingested gastric satiety device Ingested gastric satiety device Ingested gastric satiety device Ingested gastric satiety device Ingested gastric satiety device 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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