FDA.reportPublic FDA data

Unimed

Primary DI
06945664825146
Brand
Unimed
Company
Unimed Medical Supplies, Inc.
Model
F523-117
Device description
Disposable SpO2 Sensor/Adhesive Foam/GE TruSignal/Pediatric/0.9M
Published
2017-10-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142832000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142832000Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc.2015-02-06DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16945664825143PackageGS124In Commercial Distribution
06945664825146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694566482514316945664825143
06945664825146069456648251466945664825146

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter probe, single-useA photoelectric device designed to be applied externally to a body site (e.g., fingertip, ear lobe, bridge of nose, toe, or bridge of the foot) for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using signals produced by a light-emitting diode (LED) and received by a photodetector. The signals are subsequently transmitted to an oximeter/monitor (not included) which measures and displays the SpO2. The is a single-use device.

Regulatory Flags#

DUNS number
527971025
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06936735480913UnimedU708-912023-02-01
06945664833790UnimedHPMA5-90DS2016-08-22
06945664833837UnimedMQM5-90DS2016-08-22
06945664833875UnimedLQ5-90DP02016-08-22
06945664833905UnimedHTM5-90DS2016-08-22
06945664833974UnimedMQM3-90DS2016-08-22
06945664834063UnimedLQ5-90DS02016-08-22
06945664834186UnimedATM5-90DS2016-08-22
06945664834193UnimedD3M-90DS2016-08-22
06945664834209UnimedHPM3-90DS2016-08-22
06945664834254UnimedLDT3-90DP02016-08-22
06945664834414UnimedLHT5-90DP02016-08-22
06945664834452UnimedHP5-90DPM2016-08-22
06945664834469UnimedLPA5-90DS02016-08-22
06945664834537UnimedLPA5-90DP02016-08-22
06945664834735UnimedL5-90DP02016-08-22
06945664835046UnimedMQM5-90DP2016-08-22
06945664835077UnimedLKB6-90DP02016-08-22
06945664835084UnimedL3-90DP02016-08-22
06945664835640UnimedLHT5-90DS02016-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06931973400563CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973400730CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973400785CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410326CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410333CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410340CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410364CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410371CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410388CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410395CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410401CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410418CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410425CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410432CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410449CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410456CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410647CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410678CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410685CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410692CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410715CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410722CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410739CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410746CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410753CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410760CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410777CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410784CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410791CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410807CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09