Atlas Healthcare LLC

FDA Device Registration & Listing · Miami, FL, US · Registration 3029802606

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
3029802606
FEI Number
3029802606
Entity Name
Atlas Healthcare LLC
City/State/Country
Miami, FL, US
Establishment Address
411 Ne 52nd St, Miami, FL 33137, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Atlas Healthcare LLC (Owner Number: 10089018)
Owner / Operator Contact Address
2232 Dell Range Blvd, Ste 245-3569, Cheyenne, WY 82009, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K162258
PMA Number
N/A

All Registered Proprietary Names

SomaGuard Autoclave Indicator Tape SomaGuard Patient Bibs SomaGuard Surgical Face Masks SomaGuard Self-Sealing Sterilization Pouches

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2025-08-03
KHR Absorber, Saliva, Paper Dental Class 1 872.6050 2025-08-03
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2025-08-03
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2025-08-03
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2025-08-03

Official Correspondent

Adam Rosenbloom

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Atlas Healthcare 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
K201622 Guangdong Kingfa Sci. & Tech.Co., Ltd. Medical surgical mask 2020-11-24
K881618 3M Company ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK 1988-05-09

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-2007 N/A 2
3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029802606. Last updated year: 2026. Please use registration number 3029802606 when referencing this establishment in official correspondence.
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