Identity
- Trade Name
- RapidPort® EZ Port Applier FDA UDI
- Generic Name
- Infusion/injection port/tack applicator FDA UDI
- Device Name
- RapidPort® EZ Port Applier Tool FDA UDI
- Model / Reference
- C-20390 FDA UDI
- Description
- RapidPort® EZ Port Applier Tool FDA UDI
Identifiers
- Catalog Number
- C-20390 FDA UDI
- Primary DI / UDI-DI
- 00850007764906 FDA UDI
- PMA Number
- P000008 FDA UDI
- FDA Product Code
- LTI FDA UDI
- GMDN Term
- Infusion/injection port/tack applicator FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Infusion/injection port/tack applicator
RapidPort® EZ Port Applier by ReShape Lifesciences Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
P000008 also covers:
- LAP-BAND® AP System Large with RapidPort® EZ — ReShape Lifesciences Inc.
- LAP-BAND® AP System Standard with RapidPort® EZ — ReShape Lifesciences Inc.
- LAP-BAND® System Access Port Needle, 20G x 51 mm (2 in.) — ReShape Lifesciences Inc.
- LAP-BAND® System Access Port Needle, 20G x 89 mm (3.5 in.) — ReShape Lifesciences Inc.
- RapidPort® EZ Access Port Kit for use with LAP-BAND® AP System Large — ReShape Lifesciences Inc.
- RapidPort® EZ Access Port Kit for use with LAP-BAND® AP System Standard — ReShape Lifesciences Inc.
- ReShape Lap-Band® 2.0 FLEX, Large — ReShape Lifesciences Inc.
- ReShape Lap-Band® 2.0 FLEX, Standard — ReShape Lifesciences Inc.
- ReShape Lap-Band® 2.0, FLEX & Access Port, Large — ReShape Lifesciences Inc.
- ReShape Lap-Band® 2.0, FLEX & Access Port, Standard — ReShape Lifesciences Inc.
- ReShape Lap-Band® 2.0, FLEX Tubing Kit — ReShape Lifesciences Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ReShape Lifesciences Inc.
Sources (1)
- FDA UDI 856ff5b7-f40e-43b9-aa3f-b6d4af73986c 37 fields · synced Jun 1, 2026