HEALTHTEX DISTRIBUTORS, INC.

FDA Device Registration & Listing · Miami, FL, US · Registration 3000206696

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
3000206696
FEI Number
3000206696
Entity Name
HEALTHTEX DISTRIBUTORS, INC.
City/State/Country
Miami, FL, US
Establishment Address
3555 NW 41 Street, Miami, FL 33142, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Healthtex Distributors, Inc. (Owner Number: 10027903)
Owner / Operator Contact Address
3555 NW 41 Street, Miami, FL 33142, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Digital Thermometer Gown Oximeter Acurio Face Mask Oximeter Thermometer Thermometer

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2020-04-04
OEA Non-Surgical Gown General, Plastic Surgery Class 1 878.4040 2020-04-21
DQA Oximeter Cardiovascular Class 2 870.2700 2020-11-11
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2020-07-24
DQA Oximeter Cardiovascular Class 2 870.2700 2020-10-15
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2020-04-04
SDV Clinical Electronic Thermometer General Hospital Class 2 880.2910 2025-07-28

Official Correspondent

Yvette Barreto

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Healthtex Distributors, 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
K010462 Avita Corporation AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES) 2001-04-11
K760421 Arbrook Mfg. Corp. THERMOMETER, SURVALENT-ELECTRONIC 1976-08-23
K813409 Yellow Springs Instrument Co., Inc. MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER 1981-12-18
K830039 Science Development Corp. SDC RECTAL TEMP. PROBE PRODUCT #1020 1983-02-23
K842199 Sharp Electronics Corp. ELEC. DIGITAL THERMOMETER MT-20 & 30 1984-07-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0020-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M, Part Number CS08653
Z-0029-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M W/PRINTER, Part Number CS08659

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3000206696. Last updated year: 2026. Please use registration number 3000206696 when referencing this establishment in official correspondence.
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