IDS

FDA Device Registration & Listing · Indianapolis, IN, US · Registration 3015146106

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
3015146106
FEI Number
3015146106
Entity Name
IDS
City/State/Country
Indianapolis, IN, US
Establishment Address
5425 Exploration Drive, Indianapolis, IN 46241, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
IDS (Owner Number: 10062213)
Owner / Operator Contact Address
5425 Exploration Drive, Indianapolis, IN 46241, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Pulse oximeter Ear Scope / Smart Otoscope Digital Oral Thermometer

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQA Oximeter Cardiovascular Class 2 870.2700 2025-12-03
ERA Otoscope Ear, Nose, Throat Class 1 874.4770 2025-12-03
SDV Clinical Electronic Thermometer General Hospital Class 2 880.2910 2025-12-03

Official Correspondent

Mustafa Almarhoon

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

IDS
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
K903523 Hewlett-Packard Co. HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE 1990-10-23
K973147 Nellcor Puritan Bennett, Inc. NPB-295 PULSE OXIMETER 1997-11-14
K231243 Guangdong Genial Technology Co., Ltd. Finger Clip Pulse Oximeter 2023-10-31
K971628 Somanetics Corp. SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) 1997-10-10
K153184 Shenzhen Caremed Medical Technology Co., Ltd. Caremed Reusable & Disposable SPO2 Sensors 2017-01-04

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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3013418500 Quintana Supply, a division of Thomas Scientific Haverhill, MA, US
9614470 RADIOMETER BASEL AG BASEL Basel-Stadt, CH
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015146106. Last updated year: 2026. Please use registration number 3015146106 when referencing this establishment in official correspondence.
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