FDA.reportPublic FDA data

Pro Comfort Pulse Oximeter

Primary DI
00850632007539
Brand
Pro Comfort Pulse Oximeter
Company
HOME AIDE DIAGNOSTICS, INC.
Model
C101B1
Device description
Non- Invasive measurement of arterial blood oxygen saturation and pulse rate.
Published
2020-03-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173123000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173123000Pulse OximeterShenzhen Imdk Medical Technology Co., Ltd.2018-08-13DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850632007536PackageGS1200In Commercial Distribution
00850632007539PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085063200753610850632007536
00850632007539008506320075398506320075390850632007539

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeterAn electrically-powered photoelectric device designed for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals are produced by light-emitting diodes (LEDs) and received by a photodetector. The device displays the SpO2 values and may also measure/display pulse rate. It is typically applied to the fingertip or around the wrist, may be single-component (with built-in probe) or multi-component (includes external probe), and may in addition wirelessly transmit measurements to a receiving location (e.g., central station, bedside monitor); it is intended to be operated by laypersons and healthcare providers.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-800-915-0116info@homeaide.us

Regulatory Flags#

DUNS number
783518983
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860015635518Ultra-Care Disposable Safety Lancets 30GUCSLAN2026-05-05
00850071765069Easy Comfort Safety Lancets 30G 100cntECSLAN2026-05-01
00891237001195Easy Step Blood Glucose Test Strips 50ctT5D2-0011952016-05-03
00891237001423Easy Trak Blood Glucose Test Strips 25ct20002004914232016-05-03
00891237001485Easy Talk Blood Glucose Testing Strips 25ct881814852016-05-03
00891237001645Easy Plus II Blood Glucose Testing Strips 25ct881816452016-05-03
00850027494654"Easy Comfort Syringes 31G 5/16"" 0.3CC"46542024-10-08
00850027494661"Easy Comfort Syringes 31G 1/2"" 0.3CC"46612024-10-08
00850027494975Easy Comfort Pro Insulin Syringes 31g 5/16” 1cc 40 count49752024-10-08
00850027494982Easy Comfort Pro Insulin Syringes 30g 5/16” 1cc 40 count49822024-10-08
00850027494999Easy Comfort Pro Insulin Syringes 30g 0.5in 1cc 40 count49992024-10-08
00891237001034Comfort Heal Heating PadJY610110342018-02-14
00850027494517Smart Neb Pediatric NebulizerSNebPN2023-11-03
00850632007225Easy NebMCN-S600MB72252018-01-26
00850632007553Pure Air Mini NebulizerMCN-S600A2020-03-24
00891237001607Easy Air Compressor NebulizerMCN-S600MC16072016-05-01
00850058864082Easy Comfort 3L Sharps Container {3.17 Quarts}SC3L2024-06-14
00850027494340True Comfort Knee Compression Wrap43402024-10-08
00850027494357Pure Comfort Leg Massager43572024-10-08
00850027494388Ultra Comfort Body Massager43882024-10-08

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