Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006500694

FEI Number

3006500694

Entity Name

PHARMACARIBE LLC

City/State/Country

Naples, FL, US

Establishment Address

980 Palm View Drive #104, Naples, FL 34110, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Pharmacaribe LLC (Owner Number: 10035899)

Owner / Operator Contact Address

980 Palm View Drive #104, Naples, FL 34110, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K091862

PMA Number

N/A

All Registered Proprietary Names

PulmoSal pH 7.4, 0.9%, 3%, 3.5%, 6%, 7%, 10% Nessi Spacer OTC NESSI Rx

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2014-11-28
NVO	Spacer, Direct Patient Interface	Anesthesiology	Class 2	868.5630	2011-03-31
NVO	Spacer, Direct Patient Interface	Anesthesiology	Class 2	868.5630	2011-03-31

Official Correspondent

Karen Warner

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Pharmacaribe LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07

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3018783526	CEVA LOGISTICS NETHERLANDS BV (Venray)	Oostrum Limburgh, NL
3005998497	SUNMED AP, LTD.	ZHUHAI Guangdong, CN
3006852037	Omron Healthcare Manufacturing Vietnam Co., Ltd.	Ho Chi Minh City, VN
3006783791	GaleMed (Xiamen) Co., Ltd.	XIAMEN Fujian, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006500694. Last updated year: 2026. Please use registration number 3006500694 when referencing this establishment in official correspondence.