FDA.reportPublic FDA data

TOPCARE

Primary DI
10036800023427
Brand
TOPCARE
Company
TOPCO ASSOCIATES, LLC
Model
52-50K
Device description
TOPCARE PULSE OXIMETER
Published
2020-08-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082641000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082641000FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DLContec Medical System Co., Ltd.2008-11-10DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10036800023427PackageGS124In Commercial Distribution
00036800023420PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1003680002342710036800023427
00036800023420000368000234200368000234200036800023420

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter probe, reusableA photoelectric device applied externally to a body site, e.g., a fingertip, ear lobe, the bridge of nose, a toe, or the bridge of the foot of a paediatric or adult patient for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using light detection. The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector, are received by an oximeter to which this device is connected. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., electrocardiogram (ECG). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-423-0139topcare@topco.com

Regulatory Flags#

DUNS number
072943876
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00036800028326TopCare Health6 Days Sooner Pregnancy TestN/A2026-07-13
00036800028333TopCare Health6 Days Sooner Pregnancy TestN/A2026-07-13
00036800028340TopCare Health6 Days Sooner Pregnancy TestN/A2026-07-13
00036800028357TopCare Health6 Days Sooner Pregnancy TestN/A2026-07-13
00036800216587TopCare health0368002165872019-07-31
00036800216600TopCare health0368002166002019-07-31
00036800413634TopCare health0368004136342019-10-31
00036800024892TopCare health0368000248922026-02-05
10036800024899TopCare health0368000248922026-02-05
00036800024908TopCare health0368000249082026-01-30
10036800024905TopCare health0368000249082026-01-30
00036800022683TopCare HealthTOP4045V2TOP4045V22026-01-27
80368000226834TopCare HealthTOP4045V2TOP4045V22026-01-27
20036800367436TopCare Premium Blood Glucose Meter8000-071642016-09-24
00036800250789TopCare Insulin Syringe1029122016-10-04
00036800250826TopCare Insulin Syringe0331082016-09-24
20036800367443TopCare Premium Blood Glucose Test Strips8000-071582016-09-24
20036800422159TopCare Premium Blood Glucose Test Strips8000-104432016-09-24
00036800250796TopCare Insulin Syringe0330082016-09-24
00036800250802TopCare Insulin Syringe0530082016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048675785910Masimo SpO2 Module for Vista 300/SShanghai Draeger Medical Instrument Co.,Ltd.DQA2026-07-13
00010939962218N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00093351041099N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013550N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013567N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113849N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113856N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
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
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06931973410371CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
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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