FDA.reportPublic FDA data

Vasomedical™ EZ™ O2 A Adult Pulse Oximeter

Primary DI
00817980021402
Brand
Vasomedical™ EZ™ O2 A Adult Pulse Oximeter
Company
VASOMEDICAL, INC.
Model
Model EZ
Catalog number
A13-0002-03-01
Device description
EZ™ O2 A Adult Pulse Oximeter
Published
2016-11-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
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
K063641000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063641000PC-60, NON-INVASIVEPULSE OXIMETERShenzhen Creative Industry Co., Ltd.2007-07-13DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817980021402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817980021402008179800214028179800214020817980021402

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter, battery-poweredA portable, battery-powered, photoelectric device intended for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector in a probe, or directly built-in, are used to make the measurements using the principle of spectrophotometry. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., pulse rate, electrocardiogram (ECG). The device is typically applied to the fingertip or around the wrist; it may be used by healthcare facilities, emergency services, or in the home.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity095 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(516)508-5818eohara@vasomedical.com

Regulatory Flags#

DUNS number
197210248
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008179800205592GB SD Memory CardModel 1303A10-00112016-11-29
008179800205663-Ch ECG Holter Patient Cable w/5 LeadsModel 1303A10-00522016-11-29
008179800205733-Ch ECG Holter Patient Cable w/7 LeadsModel 1303A10-00532016-11-29
0081798002058012-Ch ECG Holter Patient Cable w/10 LeadsModel 1304A10-00542016-11-29
00817980020597USB SD Card ReaderModel 1303A10-00152016-11-29
00817980020603Infared Communication AdaptorModel 1805A10-00222016-11-29
00817980020610Portable Case w/Belt for 1303 RecorderModel 1303A10-00412016-11-29
00817980020627Portable case with Belt for 1304/1305 RecorderModel 1304A10-00422016-11-29
00817980020634Portable case with Belt for 1805 MonitorModel 1303A10-00502016-11-29
00817980020641Portable case with Belt for 2301/2302 RecordersModel 2301A10-00432016-11-29
008179800208703 Lead Integrated ECG Cable (AngioNew® V & VI)Model AngioNew VIA12-00332016-11-29
008179800208873 Lead Integrated ECG Cable (Models MC2, TS4 and Lumenair™)Model LumenairV10-00172016-11-29
008179800208943 Lead Integrated ECG Cable with adapter (Model TS3)Model TS3V10-00212016-11-29
00817980020900ECG Cable Adaptor-for use with V10-0017 (Model TS3)Model TS3V83-00662016-11-29
00817980021198Finger Plethysmograph (Models TS3 and TS4)Model TS-4V83-00062016-11-29
00817980021204Finger Plethysmograph (Model MC2, AngioNew® V& VI)Model AngioNew VIV23-00072016-11-29
00817980021419Vasomedical™ EZ™ O2 P Adult/Pediatric Pulse OximeterModel EZA13-0002-05-012016-11-29
00817980021426Vasomedical™ EZ™ Pediatric Probe for EZ™ O2 P (children over 3 yrs & Sm.Adults)Model EZA13-00702016-11-29
00817980021433Vasomedical™ EZ™ O2 Wrist Pulse OximeterModel EZA13-0002-02-012016-11-29
00817980021440Vasomedical™ EZ™ Software CD and Data Cable for Wrist Pulse OximeterModel EZA13-00412016-11-29

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10884521855403NellcorCovidien LPDQA2026-05-29
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