REMSLEEP HOLDINGS INC

FDA Device Registration & Listing · Blackshear, GA, US · Registration 3022159083

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3022159083
FEI Number
3022159083
Entity Name
REMSLEEP HOLDINGS INC
City/State/Country
Blackshear, GA, US
Establishment Address
3222 Hwy 84, Suite 101, Blackshear, GA 31516, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Remsleep Holdings Inc (Owner Number: 10084751)
Owner / Operator Contact Address
3222 Hwy 84, Suite 101, Blackshear, GA 31516, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K233415
PMA Number
N/A

All Registered Proprietary Names

DELTAWAVE Nasal Pillows System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2025-04-10

Official Correspondent

TOM WOOD

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Remsleep Holdings Inc
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
K792722 Novametrix Medical Systems, Inc. NOVAMETRIX CPAP NASAL CANNULA 1980-01-24
K082979 Resmed, Ltd. S8 ADVANCE 2009-01-02
K203126 Resmed Pty , Ltd. S10 Kirra 2020-12-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0009-2020 TELEFLEX-MORRISVILLE 2
Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Z-0020-2020 Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan 2
Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Z-0021-2020 Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan 2
Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Z-0022-2020 Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan 2
Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022159083. Last updated year: 2026. Please use registration number 3022159083 when referencing this establishment in official correspondence.
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