RapidPort® EZ Port Applier C-20390
GUDID 00850007764906
RapidPort EZ Applier Tool
Reshape Lifesciences Inc.
Infusion/injection port/tack applicator| Primary Device ID | 00850007764906 |
| NIH Device Record Key | 856ff5b7-f40e-43b9-aa3f-b6d4af73986c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RapidPort® EZ Port Applier |
| Version Model Number | C-20390 |
| Catalog Number | C-20390 |
| Company DUNS | 144998551 |
| Company Name | Reshape Lifesciences Inc. |
| Device Count | 1 |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Use if Package is Damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged and consult instructions for use |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850007764906 [Primary] |
| GS1 | 10811955020053 [Previous] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P000008
FDA Product Code
| LTI | Implant, Intragastric For Morbid Obesity |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-01-11 |
| Device Publish Date | 2021-01-01 |
Devices Manufactured by Reshape Lifesciences Inc.
| 00850007764500 - ReShape Lap-Band® 2.0 FLEX, Standard | 2024-01-30 ReShape Lap-Band® 2.0 FLEX, Standard |
| 00850007764517 - ReShape Lap-Band® 2.0 FLEX, Large | 2024-01-30 ReShape Lap-Band® 2.0 FLEX, Large |
| 00850007764548 - ReShape Lap-Band® 2.0, FLEX & Access Port, Standard | 2024-01-30 ReShape Lap-Band® 2.0, FLEX & Access Port, Standard |
| 00850007764555 - ReShape Lap-Band® 2.0, FLEX & Access Port, Large | 2024-01-30 ReShape Lap-Band® 2.0, FLEX & Access Port, Large |
| 00850007764586 - ReShape Lap-Band® 2.0, FLEX Tubing Kit | 2024-01-30 ReShape Lap-Band® 2.0, FLEX Tubing Kit |
| 00850007764258 - ReShape Calibration Tubes | 2023-03-24 Calibration and Sizing Tube 32 French |
| 00850007764265 - ReShape Calibration Tubes | 2023-03-24 Calibration and Sizing Tube 36 French |
| 00850007764272 - ReShape Calibration Tubes | 2023-03-24 Calibration and Sizing Tube 40 French |
Trademark Results [RapidPort]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RAPIDPORT 78561169 not registered Dead/Abandoned |
ALLERGAN, INC. 2005-02-04 |
 RAPIDPORT 77645578 3871043 Live/Registered |
APOLLO ENDOSURGERY US, INC. 2009-01-08 |
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